Amico

In-Plant Training Report
On
Amico Laboratories Limited

Khagan, Savar, Dhaka
Submitted by
Nusrat Jaman 2015000300066
Mahmuda Khanam 2015000300067
Golam Dosragir Al-Rahi Khan 2015000300076
Mehedi Hassan Shaon 2015000300084
Md. Rimon Hossain 2015000300087
Md. Tariq Bin Aziz 2015000300127
Southeast University
Submitted to
Muhammad Ruhul Amin
Asstt. Manager, QC
Amico Laboratories Limited
Submission Date: 14th March, 2019

ACKNOWLEDGEMENT
First of all thanks to Almighty Allah for his favor as I have got chance to complete
the industrial training at Amico Laboratories Ltd.
We, as the students of Department of Pharmacy of Southeast University of

Bangladesh, consider ourselves very lucky to have the opportunity of in-plant
training at Amico Laboratories Ltd.
We would like to thank, Mojibul Islam (Panna) acting Managing Director, Al-Haj
Md. Mockbul Hossain Chairman, Md. Parvez Sazzad Factory in-charge, Md. Nurul
Islam, Production Manager for providing us the training facilities in this factory.
Our grateful thanks to Muhammad Ruhul Amin, Asstt.Manager of QC; Md. Rakib
Uddin, Najnin Sultana,Tania Khanum,Israt Jannat Executive of QC for taking
initiative in plant training program.
My Special thanks to company adviser Dr. Saiful Isalm; Dean of faculty of

Dhaka University.
Finally thanks to all Amico Laboretories Ltd people for their every friendly co-
operation.
With Regards
Sayedatun Nur Samira
Mohammad Abu Sufian
Abdur Rahman
Md. Mukter Hossain
Md. Sharif Ahammed
Table of Content
SI. No. Heading Page no
1. Introduction 1-2
2. Warehouse 3-7
3. Production Department 8-9
4. Tablet Section 10-34
5. Capsule section 35-39
6. Quality assurance & validation 40-42
7. Quality control department 43-54
8. Packaging department 55-58
9. Product development department 59-61
10. Products 62-77
11. Marketing Planning Department 78

(MPD)
12. Conclusion 79
Introduction 1
Introduction
Amico Laboratories Limited, also known as Amico Laboratories is a major pharmaceutical
company based in Bangladesh. It is part of the Mona Group of Companies.
Corporate history
Amico laboratories Limited has emerged one of the fastest growing Pharmaceutical companies in
Bangladesh for manufacturing & marketing of human health care products.
Factories
The Factory is situated at the heart of the Industrial area in the capital city – Dhaka. The factory
consists of Production department, R & D department, Accounts department and various other
sub-departments. The factory is operating with over 350 employees. It is equipped with
sophisticated and modern production and quality control equipment.
Amico Laboratories Limited. Type Ltd Industry Pharmaceutical, Founded 1976 Headquarters
Tejgaon, Dhaka, Bangladesh Key people Al-Haj Mockbul Hossain
Website: http://www.amicolab.com/
Name of the Company: Amico Laboratories Limited
Change of Ownership and re-operation: 1994 July
Business type: Manufacturer, Marketer and Distributor of medicine & drugs
Ownership: Private Limited Company
Managing Director: Mojibul Islam (Panna)
Chairman: Al-Haj Mockbul Hossain
Group: A sister concern of Mona Group of Industries
Factory: Khagan, Birulia, Savar at Dhaka.
Marketing Office: 22/10, Babor Road, Block:B, Shaymoli, Dhaka-1207
ISO Certicate No. : 94210, Issue No. – 1

Introduction
Amico laboratories Limited has emerged one of the fastest growing Pharmaceutical
companies in Bangladesh and dedicated towards manufacturing & marketing of human health
care products. In this fast paced competitive business environment, Amico focuses on quality
& efficacy of products. Amico Laboratories Limited strictly follows GMP (Good
Manufacturing Practices). It has always been our endeavour to create an environment where
in innovation of the highest order can blossom. To Keep our commitment on quality, we have
worked hard to achieve ISO 9001:2000 for Quality Management System. This international
recognition has enhanced out reputation with pride & dignity. The company, with its clear
vision, marketing policies and long-term vision on customer satisfaction, has already created
a favourable image in all over Bangladesh. With moderate product range, professional
attitude and focused marketing policies, the company has availed a strong track record so far.
Amico Laboratories Limited, indeed, is a newborn baby in the pharmaceutical industry and
still has many more to offer to serve the nation with its health care products. Its increasing
growth rate indicates a promising future.
Amico laboratories limited has now total 161 products.
Product Type
Tablets (coated-film coated / uncoated)

Capsules
Dry Powder for suspension
Syrup
Lotion
Emulsion
Cream
Ointment
Warehouse 3
Warehouse
It is an area where raw materials and packaging materials are received, stored, dispensed and
distributed as per office requisition. Ware House is the place where materials for the
production are stored for further use and distribution. Amico Laboratories Ltd. has a striking
ware-house where raw, packaging and finished products are stored with great care.
Fig :- Warehouse
 Ware-house has a-
 Quarantine Area
 Approved Products Area
 Reject Products Area
 Packaging Components Area
 Area for Bulk Products
 Area for finished Goods
 Separate Sampling Area
 Cool Room
 Cold Room
 Empty Hard Gelatin Capsule

In-Plant Training Report On Amico Laboratories Limited
Warehouse 4

Documentation
Ware-house should be clean and well maintained and appropriate temperature 24°C
Different Units of Warehouse

 Storage for Raw material.
 Storage for Packing material.
 Storage for Finished product.
 Storage for Thermo labile product (Foster/cold storage).
Flow chart of Incoming material flow

Vacuum clean all incoming material containers in the loading bay area
↓
Record incoming material received
↓
Visual inspection of incoming material
↓
Status labeled QUARANTINE
↓
Transfer to Quarantine area
↓
Warehouse department is to inform the QA /QC department
↓
Sampling and testing by QA /QC department

↓
Status labeled released Status labeled rejected

↓ ↓
Transfer to release area Transfer to a segregated room under lock and key, kept till
destruction.

Warehouse 5
Areas of Warehouse
1. Quarantine area: After receiving, raw materials and packaging materials are kept here for
QA approval. Area is located in the front portion of the building.
2. Released area: Approved raw materials and packaging materials are generally stored in
the central place of the warehouse with great safety.
3. Rejected area: Rejected raw materials, packaging materials, finished products are stored
here with great care. The rejected area is located at corner portion of the warehouse in a
Separater oom, where entry is strictly regulated.
4. Finished Products area: Finished products are stored here for delivery.
5. Special area: It includes cold room, freeze room for poisonous materials, room for
flammable materials.
Activities of Warehouse
Warehouse activities can be stated as follows: (related to raw and packaging materials)
 Arrival of materials.
 Invoice checking.
Physical inspection & receipt/discrepancy report.
 Quarantine storage.
 QA sampling.
 Leveling in the container.
 Entry in SAP.
 QA release/ rejected materials.
 Dispensing of released/ rejected materials.
 Dispensing / Distribution.

Warehouse 6
Fig:– Dispensing Booth
Some common terms of Ware house

Sampling
As the process of taking a small portion from a lot for test and analysis to show the quality of
the whole lot. The purpose of sampling and subsequent testing is to provide an effective
check on the quality of the product or substances being processed.
Sampling quantity
Sampling quantity should be the double of one complete test.
Lot
A batch or number of batches in a consignment.
Batch
A quantity of the product or material which is processed in one run following manufacturing
USP.
Campaign
A campaign means number of batches manufactured without any interruption or product
change.
Handling
The term handling means checking according to invoice/challan and other documents during
receiving of the materials.

Warehouse 7
Preservation
The term preservation means the materials are stored in different conditions according to its
nature of stability i.e. to maintain a specific temperature and relative humidity.
Dispensing
Dispensing means the materials are supplied to the production areas by weighing according to
the proper document and release it from the RM Store.
Quarantine
The term quarantine means the material is not ready for use and it is under test after received.
So a quarantine label is attached to the container.
 FIFO: The term FIFO stands for First In First Out.
 Re-test: The term re-test means the samples are needed to be repeated analysis for
identify vs. previous documentation and it has been done either 3/6/12 months.

Production Department 8
Production Department
Production area is the major section of pharmaceutical industry where men, machine and
material are brought together to produce a product of quality. In other words, it is the heart of any
pharmaceutical industry. Our training program me would be incomplete without visiting
production area.
Room available in Production area
 Change Room
 Office Room
 Dispensing Room
 Liquid Dispensing Room
 Clean equipment Store room
 Washing Bay
 IPC
 Granulation Room
 Compression Room
 Coating Room
To maintain GMP the following facilities are available
 Adequate space
 PRW (purified water) supply
 HVAC (Heating Ventilation Air Conditioning) supply

Production Department 9
The Production area is meanly classified into two major areas.
 Solid Production
← Tablet (Estrogenic, Non-estrogenic)

← Capsule
 Parenteral Production
← Ampoule
SOLID PRODUCTS
Solid products are administered orally. As this contains a quantity of drug, which is given a
single unit, they are collectively known as solid unit dosage forms.
Solid products included
1. Tablet.
2. Capsule.
3. Dry syrup

Tablet Section 10
Tablet Section
Tablets are the solid unit dosage form of medicament with or without suitable diluents and made
by compression. It is the mostly used dosage form.
Operation in tablet section
 After the recommendation for the production of a batch, at first the requisition of required
raw materials is sent to ware house department.
 QA/QC approved required raw materials of specific amount is then sent to the dispensing
unit.
 A list of chemicals with corresponding specific weight is hung in dispensing unit.
 Accurate weighing of chemicals.
 Remaining materials with a document containing amount used and amount loss is returned to
ware house department.
 Mixing and granulation.
 Compression.
 Coating (if necessary).
 Packaging and packing.
Each step is carried out according to Standard Operating Procedure (SOP).

Tablet Section 11
Precautions taken during manufacturing of tablet in Amico Laboratories Ltd.
 Room, floors, machineries and other tools involved in manufacturing are checked for
proper cleanliness everyday
 During changeover, floor of every area in this section are cleaned properly by a vacuum
cleaner.
 Then it is washed with savlon water using cloth.
 Wall, door, glass other furniture are cleaned with savlon water using a clean cloth.
 After completion of daily work, each area of this section is cleaned in the same process.
 After cleaning the machineries are labeled as “clean”, which is confirmed by the QC
personnel. Only after confirmation, these are used for next production.
Tablet Production department has the following units
 Dispensing
 Granulation
 Compression
 Coating
Dispensing Unit
1. Requisition is given to warehouse for raw materials prior to granulation.
2. Raw materials are collected from warehouse through air lock and transferred to a clean
dispensing room.
3. Before transferring the raw materials to the dispensing room following things should be
checked
4. Materials are checked according to requisition
5. Label check i.e. material is either quarantine, released or rejected

Tablet Section 12
Yellow label indicate—> Quarantine
Green label indicate—> Released
Red label indicate—> Rejected
 Mfg. date
 Exp. date.
 Dispensing condition (Temp, RH %) should be maintained.

 Weighing raw materials according to DOS (Dispensing Order Sheet)
 Checking of quantity dispensed.
 Excess material returned to warehouse.
Granulation Unit
Granulation is the process in which the powder particles of raw materials are made to form
particles in order to facilitate compression for the production of tablet. All the materials are
received from dispensing unit and the granulation is performed.
Granulation is the process in which primary powder particles are made to adhere to form larger,
multiparticulate entities called granules.
Pharmaceutical granules typically have a size range between 0.2 and 4.0mm depending on their
subsequent use.
However, in the majority of the cases, this will be for the production of tablets and capsules.
when granules will be made as an intermediate product and have a typical size range between 0.2
and 1mm.

Tablet Section 13
Reasons for granulation

1. To prevent segregation of the constituents of the powder mix
Segregation means demixing and are mainly due to particles size, density and shape differences.
 To improve the flow properties of the mix
 To improve the compaction properties of the mix
Other reasons:
a. To reduce the hazard associated with the generation of toxic dust that may arise during
handling.
b. To reduce the possibility of caking when stored at least for hygroscopic products
c. More convenient for storage or shipment. Sine granules being denser than the parent powder
and occupy more space.
The solvents used in granulation method (mainly in wet) are typically include, Water,
ethanol, Isopropanol, Isopropyl alcohol (IPA), either alone or in combination.
Granules are characterize by

a. Size and size distribution
b. Shape
c. Surface area
d. Density, Strength and Friability
f. Flow properties
g. Compaction properties.

Tablet Section 14
Steps of granulation process
Types of Granulation
1. Direct Compression
2. Dry Granulation
3. Wet Granulation

Tablet Section 15
Steps of Direct Compression
Raw material weighing Sieving
Compression Blending
QC
QC Test Test
Wet Granulation Unit
Wet granulation is the popular technique because the granules made by this process meet almost
necessary physical requirements.
Steps of Wet Granulation
Weight checking of Sieving Dry mixing in

raw materials Mass mixer
Initial drying in Fluidized Wet mixing Addition of Starch

bed dryer
Paste/Povidone solution

Tablet Section 16
Milling/ Sizing Granules Final drying
Compression Lubrication
Advantages and Disadvantages of wet granulation

1. The cohesiveness and compressibility of powders is improved due to the added binder that
coats the individual powder particles
2. Drugs having a high dosage and poor flow and /or compressibility must be granulated by wet
method to obtain suitable flow and cohesion for compression.
3. Good distribution and uniform content for soluble, low dosage drugs and colour additives are
obtained if these are dissolved in the binder solution.
4. A wide variety of powder can be possessed together in a single batch and in so doing, their
individual physical characteristics are altered to facilitate tabletting.
5. Bulky and dusty powders can be handled without producing a great deal of dust and air borne
contamination
6. It prevents segregation of components of a homogeneous powder mixture during processing,

transferring, and handling.
7. The dissolution rate of an insoluble drug may be improved by wet granulation with the proper
choice of solvent and binder

Tablet Section 17
8. Controlled release dosage form can be accomplished by the selection of a suitable binder and
solvent.
Disadvantages
1. Because of large no of processing steps, it requires a large area with temperature and humidity
2. It requires a number of pieces of expensive equipment
3. It is time consuming, especially the wetting and drying equipment
4. There is a possibility of material loss during processing due to transfer of materials from one
unit to another
5. There is a grater possibility of cross contamination than with direct compression method
6. It presents material transfer problems involving the processing of sticky masses
7 It can slow the dissolution of drugs from inside granules after tablet disintegration if not
properly formulated and processed.
Machines for Granulation
Rapid Mixer Granulator (RMG) / High Shear Mixer Granulator (HSMG)-
Amico Laboratories Limited uses RMG and HSMG, Indian origin with capacity of 120-150
kg/batch
The fast moving mixer blades enforce the powder material in to spiral fiuidisationat the bowl
base.
This vortex effect in the material provides faster and uniform (even) distribution of the
ingredients. The shape of the bowl is designed to ensure an optimal and constant flow of the
processing material. This intensive mixing action distributes "active" substances homogeneously
within few minutes. By adding binder through charging hole at the top cover, particles are
uniformly moistened and aggregated to large granules.

Tablet Section 18
The vertically rotating, specially designed chopper blades shears the circulating powder and
breaks down lumps and aggregates. Thus granules attain higher density and uniformity in shape,
thereby achieving a uniform particle size distribution. The product is discharged by gravity
within a few seconds through discharge port operated by pneumatic cylinder. Product discharge
made quicker by rotating mixer blades at a slow speed.
Fluidized Bed Dryer (FBD)

In his case, Heated and fluidized air is blown or sucked through the bed of unmixed powders to
fluidize the particles and mix the powder in the granulating chamber.
Granulating fluid is pumped from a reservoir through a spray nozzle positioned over the bed of
particles and sprayed on to the bed of powders.
The fluid causes the primary particles to adhere when the droplets and powders collide.
Escape of material from the granulation chamber is prevented by exhaust filters, which are
periodically agitated to reintroduce the collected material into the fluidized bed.
Sufficient liquid is sprayed to produce granules of the required size, at which point the spray is
turned off but the fluidizing air continued.

Tablet Section 19
Advantages
 Single unit system. (All the granulation processes which require separate equipment in
the conventional method are performed in one unit thus saving labor costs, transfer losses
and time.
 The process can be automated once the conditions affecting the granulation have been
optimized.
Disadvantages
 Initially expensive and optimization of process (and product) parameter affecting
granulation needs extensive development work, not only during initial formulation work
but also during scale up from development to production. This long and very product
specific development process has proved to be a problem with fluidized-bed granulation
in the pharmaceutical industry.
 Fluidized bed systems may not provide adequate mixing of powder components. In fact
there is a tendency for demixing to occur when there are disparities in particle size or
density in the materials being processed.

Tablet Section 20
 Particles with granulating agent on their surface tend to stick to the equipment filters,
reducing the effective filter surface area, causing product loss, and increasing clean up
difficulties.
 Special attention is also needed for safety in any fluid bed processor. Dust explosion can
occur in a fluid bed dryer, with flammable solvents or with dry materials that develop
static charges. All production size fluid bed equipment must contain explosion relief
panels.
Dry Granulation
This process is applied for those of the drugs, which are sensitive to moisture. E.g. Ortac
(Ranitidine), Tone (Thiamine).
Steps of Dry Granulation
Weight checking of raw Sieving Manual

material mixing
Milling to purpose Compression Mechanical blending in

size/Granules double Cone blender
QC Test
Compression

Tablet Section 21
Dry Granulation
Slugging
 After weighing and mixing the ingredients, the mixture is slugged, or compressed into large flat tablets
or pellets about 1 inch in diameter.
 The slugs are broken up by hand or by mill and passed through a screen of desired for sizing.
 Lubricants is added
 Tablets are prepared by compression
 Aspirin which is hydrolyzed on exposure to moisture, may be prepared into tablets after slugging.
Advantage
This is valuable alternative to direct compression, where the dose of drug is too high or too wet
granulation when the drug is sensitive to heat, moisture or both.
This method is also used when other methods of granulation yield granules with poor flow or
compression properties, because there are less chances of segregation of drug and excipients.
Blending
Blending, one of the most basic of pharmaceutical unit operations, can also be one of the most
challenging to control. Solid formulations contain multiple ingredients beyond the active
pharmaceutical ingredients: fillers, tableting agents, disintegrates, and absorption enhancers or
agents that slow down and control absorption. Ingredients from different vendors may behave
differently due to their particle size and shape and other factors, and their tendency to form
aggregates.
Materials must be chosen to ensure the desired flow characteristics, potency, proper dissolution
profile, and absorption of specific formulations. Proper particle size grades of the ingredients
must be selected to produce an optimum blend for capsule filling.
Amico Laboratories Limited uses Double coned Blender and a bunker
Double Cone Blender
The Double Cone Blender is an efficient and versatile machine for mixing dry powder and
granulates uniformly.

Tablet Section 22
Two-thirds of the volume of the cone blender is filled to ensure proper mixing. Double Cone
Blender is used for pharmaceutical, food, chemical and cosmetic products, etc. These machines
are extensively used in the pharmaceutical industry to granulate and blend medicated powders. It
is also the best way to mix very heavy and abrasive products for total discharge of product with
minimal retention. Blender features multi shear deflector plates for the improved blending
efficiency of free flowing powders and granules.
Salient Features
 The conical shape at both ends enables uniform mixing and easy discharge.
 The cone is statically balanced to avoid any excessive load on the gear box and motor.
 While the powder can be loaded into the cone through a wider opening, it can be discharged-
through a mucon valve or a slide valve.
 Depending upon the product, paddle-type battles can be provided on the shaft for better
mixing.
 Maximum care has been taken ensure safe operation of the unit. It can also be operated
through a timer.
 The contact parts are made of either S.S. 304 or 316 L.

 Flame-proof motor can be supplied as option.
Bunker
Bunker is used mainly for blending of dry powders for capsule plant, for blending and
homogenizing of dried granules for tablet production.

Tablet Section 23
This is a closed and contained system where by a single step transfer material from container of
the Conta blender is transferred to the tablet press hopper.
Compression Unit
After granulation the granules are compressed to form tablets of specific weight, hardness and
thickness.
Direct compression
A few crystalline drugs such as sodium chloride, sodium bromide, potassium chloride and aspirin
may be compressed directly.
A number of materials are available which are directly compressible and which can serve as
tablet diluents for direct compression. These directly compressible diluents are inert substances
possessing good flow properties even when significant quantities of drugs are mixed with them.
Examples, directly compressible microcrystalline cellulose (Avicel), Dicalcium Phosphate

(emcopress), anhydrous and spray dried lactose, modified starch (starch 1500) directly
compressible grades of sucrose, sorbitol, mannitol and dextrose
“Direct compression is the most economical of the three methods in term of time, labor, and
equipment.
The bioavailability of the drug is usually better due to absence of adhesive binding agents.

Tablet Section 24
The elimination of moistening and drying stages prevents many of the stability problems (such
as. Hydrolysis of the drug, microbial growth in the product etc) associated with moist granulation
process.”
Compression
After the preparation of granules (in case of wet granulation) or sized slugs (in case of dry
granulation) or mixing of ingredients (in case of direct compression), they are compressed to get
final product. The compression is done either by single punch machine (stamping press) or by
multi station machine (rotary press). The tablet press is a high-speed mechanical device. It
'squeezes' the ingredients into the required tablet shape with extreme precision. It can make the
tablet in many shapes, although they are usually round or oval. Also, it can press the name of the
manufacturer or the product into the top of the tablet.
Each tablet is made by pressing the granules inside a die, made up of hardened steel. The die is a
disc shape with a hole cut through its centre. The powder is compressed in the centre of the die
by two hardened steel punches that fit into the top and bottom of the die. The punches and dies
are fixed to a turret that spins round. As it spins, the punches are driven together by two fixed
cams - an upper cam and lower cam. The top of the upper punch (the punch head) sits on the
upper cam edge .The bottom of the lower punch sits on the lower cam edge.
The shapes of the two cams determine the sequence of movements of the two punches. This
sequence is repeated over and over because the turret is spinning round. The force exerted on the
ingredients in the dies is very carefully controlled. This ensures that each tablet is perfectly
formed. Because of the high speeds, they need very sophisticated lubrication systems. The
lubricating oil is recycled and filtered to ensure a continuous supply. Common stages occurring
during compression
Stage 1: Top punch is withdrawn from the die by the upper cam Bottom punch is low in the die
so powder falls in through the hole and fills the die
Stage 2: Bottom punch moves up to adjust the powder weight-it raises and expels some powder
Stage 3: Top punch is driven into the die by upper cam Bottom punch is raised by lower cam
Both punch heads pass between heavy rollers to compress the powder
Stage 4: Top punch is withdrawn by the upper cam Lower punch is pushed up and expels the
tablet is removed from the die surface by surface plate
Stage 5: Return to stage 1

Tablet Section 25

Tablet Section 26
Coating
Many tablets today are coated after being pressed. Although sugar-coating was popular in the
past, the process has many drawbacks. Modern table coating is polymer and polysaccharide
based, with plasticizers and pigments included. Tablet coatings must be stable and strong enough
to survive the handling of the tablet, must not make tablets stick together during the coating
process, and must follow the fine contours of embossed characters or logos on tablets. Coatings
are necessary for tablets that have an unpleasant taste, and a smoother finish makes large tablets
easier to swallow. Tablet coatings are also useful to extend the shelf-life of components that are
sensitive to moisture or oxidation. Special coatings (for example with pearlescent effects) can
enhance brand recognition.
If the active ingredient of a tablet is sensitive to acid, or is irritant to the stomach lining, an
enteric coating can be used, which is resistant to stomach acid, and dissolves in the less acidic
area of the intestines. Enteric coatings are also used for medicines that can be negatively affected
by taking a long time to reach the small intestine, where they are absorbed. Coatings are often
chosen to control the rate of dissolution of the drug in the gastrointestinal tract. Some drugs will
be absorbed better at different points in the digestive system. If the highest percentage of
absorption of a drug takes place in the stomach, a coating that dissolves quickly and easily in
acid will be selected. If the rate of absorption is best in the large intestine or colon, then a coating
that is acid resistant and dissolves slowly would be used to ensure it reached that point before
dispersing.
There are two types of coating machines used in the pharmaceutical industry: coating pans and
automatic coaters. Coating pans are used mostly for sugar coating of pellets. Automatic coaters
are used for all kinds of coatings; they can be equipped with remote control panel, dehumidifier,
and dust collectors. The explosion-proof design is required for alcohol containing coatings.
Film coating
A film coating is a thin polymer-based coat applied to a solid dosage form such as a tablet. The
[1]
thickness of such a coating is usually between 20-100 µm. It is possible to follow the dynamic
curing effect on tablet coating structure by using non-destructive analytical methodologies.

Tablet Section 27
Film coating formulations usually contain the following components
1. Polymer
2. Plasticizer
3. Colourant
4. Opacifier
5. Solvent
6. Vehicle
Functionality it is further divided into
1. Immediate release coating

2. Sustained release or modified release coating
3. Enteric release coating
Name Origin Model Capacity (kg)
Conventional coater India CC-10-G1 10
Neocota 48 A India 48-A 150
Encapsulation
Encapsulation refers to a range of dosage forms—techniques used to enclose medicines—in a
relatively stable shell known as acapsule, allowing them to, for example, be taken orally or be
used as suppositories. The two main types of capsules are:

Tablet Section 28
 Hard-shelled capsules, which are typically made using gelatin and contain dry, powdered
ingredients or miniature pellets made by e.g. processes of extrusion orspheronisation. These
are made in two halves: a lower-diameter "body" that is filled and then sealed using a higher-
diameter "cap".
 Soft-shelled capsules, primarily used for oils and for active ingredients that are dissolved or
suspended in oil.
Both of these classes of capsules are made from aqueous solutions of gelling agents like:
 Animal protein, mainly gelatin;
 Plant polysaccharides or their derivatives like carrageenans and modified forms of

starch and cellulose.Other ingredients can be added to the gelling agent solution like
plasticizers such as glycerin or sorbitol to decrease the capsule's hardness, coloring
agents, preservatives, disintegrants, lubricants and surface treatment.
Standard sizes of capsules
Size Volume (ml) Locked length (mm) External diameter (mm)
5 0.13 11.1 4.91
4 0.20 14.3 5.31
3 0.27 15.9 5.82
2 0.37 18 6.35
1 0.48 19.4 6.91
0 0.67 21.7 7.65

Tablet Section 29
0E 0.7 23.1 7.65
00 0.95 23.3 8.53
000 1.36 26.14 9.91
13 3.2 30 15.3
12 5 40.5 15.3
12el 7.5 57 15.5
11 10 47.5 20.9
10 18 64 23.4
7 24 78 23.4
Su07 28 88.5 23.4

Tablet Section 30
The overall tabletting cycle is as follows
1. Hopper: Contains the granulated material which is to be tablatted.

2. Feed frame: Fed by the hopper to hold the granule as it is fed in to the die.
3. Feed paddles: Ensures that the granule is keep agitated to correct filling of the die bore.

Tablet Section 31
4. Draw-down Cam: The lower punch guide during the first part of the fill stage, adjustable
to ensure that the die bore is over filled initially to allow accurate adjustment at weight
control.
5. Weight control: The lower punch guide during the latter part of the fill stage, adjustable to
ensure that as the punch rises, the correct quantity of granule remains within the die, and
therefore the tablet dosage is correct.
6. Fill Station: The point where the die has been correctly filled.
7. Pre-compression rollers: This smaller roller gives the granule an initial pinch to remove
as much air as possible before full compression takes place.
8. Main compression rollers: Applies full pre-determined pressure to the punches for the
final formation of the tablet.
9. Compression Station: Where full compression of the tablet is achieved.
10. Ejection cam: This forms the lower punch guide during the ejection stage and is
adjustable to ensure smooth ejection without damaging tablets.
11. Take-off blade: Fitted in front of the feed frame this deflects the tablet down the take-off
chute.
12. Ejection station: This is the station where the tablet leaves the die for take-off.
13. Take-off chute: the chute down which the tablet passes for collection and packaging
Problems during Processing and Compression
Tablet production may reasonably exhibit a number of defects during the process of developing
formulation and in the routine manufacture of tablets, which are not desirable. These defects
arise due to the following reasons:
1. Wrong formulation
2. Improper setting of tablet machine
3. Processing error
Defects related to Tableting Process
i. Capping It is due air-entrapment in the granular material.

ii. Lamination: It is due air-entrapment in the granular material.
iii. Cracking: It is due to rapid expansion of tablets when deep concave punches are used.

Tablet Section 32
Capping:
Capping is the partial or complete separation of top or bottom layer of the tablets from the main
body of the tablet.
Cause:
A. Problem of formulation
B. Problem of punch
C. Problem of die
D. Incorrect setting of tablet machine
Lamination:
Lamination is the separation of a tablet into two or more distinct layers.
Reason: Air–entrapment during compression and subsequent release on ejection.
The condition is exaggerated by higher speed of turret.
Cracking:
Small, fine cracks observed on the upper and lower central surface of tablets, or very rarely on
the sidewall are referred to as ‘Cracks’.
Reason: It is observed as a result of rapid expansion of tablets, especially when deep concave
punches are used.
Coating Unit
The coated tablet imposes an additional barrier to the gastro-intestinal fluid . The coat must
dissolve before tablet disintegration and dissolution.
Purpose of coating
1) To protect the medicinal agent against destructive exposure to air and/or humidity.

Tablet Section 33
2) To mask the taste of the drug.
3) To provide special characteristics of drug release.
4) To provide aesthetics or distinction to the product.
5) To prevent inadvertent contact by non patients with the drug substance.
Types of coating
1) Sugarcoating tablets
2) Film-coating tablets
3) Enteric coating
4) Pan coating
5) Fluid-bed or air suspension coating
6) Compression coating
Classification of coating

Tablet Section 34
Problems of Coating
 Logo bridging
 Edge chipping or erosion
 Picking or sticking
 Cracking
 Core erosion
 Loss of logo definition
 Orange peel/roughness
 Twining
 Mottling
Capsule section 35
Capsule section
Capsule may be defined as solid dosage from in which one or more medicinal and/or non-
medicinal inert substances are enclosed within a small shell or container (consisting cap and
body), generally prepared form a suitable form of gelatin. Depending upon the formulation, the
gelatin capsule shell may be hard or soft.
Capsule size
Capsule shells are supplied in a number of sizes. The number varies from 000 to 5, the former
being largest and the later the smallest. The exact amount of medicament, which can be filled in
a particular size of capsule shell, depends upon density of the materials to be filled in. Generally
capacity varies from 600mg to 30 mg.
Filling Capacity of empty capsules
0 0.75
1 0.55
2 0.5
3 0.3
4 0.25
5 0.15
Capsule section 36
Stages of Manufacturing of Capsule
Receiving and dispensing of raw materials
Blending
Q.C Test
Filling
Q.C Test
Polishing
Blister
Q.C Test
Packing

Capsule section 37
Problem during capsule manufacturing
Usually the following problem occurs during encapsulation:
1. Capsule shell size variation
2. Capsule shell color variation
3. Shell lock
4. Pore of shell
5. Shell cutting is not correct
6. Two shell attaches to each other
7. Pellets become clump together
8. Charge develops on pellets surface on frequent agitation and they stick to each other
hampering the flow rate. By using talc, mg stearate the following problem can be resolve.
9. Weight variation

Capsule section 38

Capsule section 39

 Quality Assurance & Validation 40
QUALITY ASSURANCE & VALIDATION
Quality assurance is the sum total of the organized arrangements made with the object of ensuring
that products will be of the quality required by their intended use.
The assurance of product quality depends on more than just proper sampling and adequate testing
various components and the finished dosage form. Prime responsibility of maintaining products
quality during production rests with the manufacturing department.
Quality Assurance Department is responsible for assuring that quality polices adopted by a Company
are followed and in most organization it serves as the contact with regulatory agencies and are the
final authority for product acceptance or rejection. It also help tom prepare the standard operation
procedure (SOPs) relative to control of quality.
Types of work of QA
 Raw materials analysis

 Source development
 Commercial Consignment
 Re-testing
 Keeping sample & relevant documentation
 Packaging material analysis
 Source development
 Commercial Consignment
 Finish product analysis
 In process
 Bulk product
 Water analysis
 Calibration
 Validation
 Packed Product analysis
 In Process
 Packet product
 Stability study
 Product monitoring

Quality Assurance & Validation 41
 Environmental monitoring
 Dust monitoring
 Documentation
Flow Chart of Releasing Finished Product

 Collection of sample from the belt as per sampling procedure
 Recording of the Quantities of collect sample by analyst on batch packaging record sheet.
 Checking of the product
 Recording in packed product record sheet
 Reporting to the respective officer by analyst (in case of any fault)
 Collection sampling advice sheet after packing of a batch
 Allocation of the Laboratory Ref. No. to the sampling advice sheet.
 Preparing of the report after checking.
 Further checking by the officer.
 Releasing of the batch to the market by the QC Manager, if satisfactory result comes.
 Keeping of the document under supervision of QA after releasing a batch.
 In case of rejection, rejected label (s) will be pasted on the product.
Recording of the rejection details in the rejection register and authorized by QA Manager.
VALIDATION
Validation may be defined as a means to prove that an equipment or process actually performs as
per design or requirement. This is achieved by measuring any attribute that is possible to
quantify.
Types of process validation

Depending on when it is performed in relation to production, validation can be prospective,
concurrent, and retrospective or revalidation (repeated validation).
Prospective validation is carried out during the development stage by means of a risk analysis
of the production process, which is broken down into individual steps: these are then evaluated
on the basis of past experience to determine whether they might lead to critical situations.

Quality Assurance & Validation 42
Concurrent validation is carried out during normal production. This method is effective only if
the development stage has resulted in a proper understanding of the fundamentals of the process.
The first three production-scale batches must be monitored as comprehensively as possible. The
nature and specifications of subsequent in-process and final tests are based on the evaluation of
the results of such monitoring.
Retrospective validation involves the examination of past experience of production on the

assumption that composition, procedures, and equipment remain unchanged; such experience
and the results of in-process and final control tests are then evaluated. Recorded difficulties and
failures in production are analyzed to determine the limits of process parameters. A trend
analysis may be conducted to determine the extent to which the process parameters are within
the permissible range.
Revalidation is needed to ensure that changes in the process and/or in the process environment,
whether intentional or unintentional, do not adversely affect process characteristics and product
quality.
Revalidation may be divided into two broad categories:
1. Revalidation after any change having a bearing on product quality.

2. Periodic revalidation carried out at scheduled intervals.
Purpose of Validation
Validation is carried out to have better control of the manufacturing and related operations to
ensure minimum deviations in actual production from the ones required by design. The benefit of
such validation exercises therefore include better system control and maintenance and a high
degree of assurance that a specific process will consistently produce a product meeting its
predetermined specifications and quality characteristics

Quality Control Department 43
QUALITY CONTROL DEPARTMENT

Quality Control
Quality control is that part of GMP which is concerned with sampling specification and testing
and with organization documentation and release procedures which ensures that the necessary
and relevant tests are infact carried out and that materials are not released for sale or supply untill
this quality has been judged to be satisfactory.
Activities of the Quality Control Department
 Receiving of the samples to be tested from QA department.

 Issuing release, reject or quarantine advice for each batch of raw material and final
product.
 Assessment of the intermediate products & bulk products for further processing
 Performing all tests procedure for all incoming samples according to the shedule.
 Maintaining batch wise full quality control tests records & signature of the.
 Person(s) who perform the test.
 Performing environmental monitoring tests.
 Calibrations and standardization of laboratory equipment’s.
 Ensuring precision and accuracy of all testing methods.
 Control of all laboratory reagents.
 Research & development of any new method & its validation.
 Testing of any return goods.
 Stability tests for finished products
Working Division of Quality Control Department

Quality Control (QC) department can be further divided into four corresponding section:
 Microbiological section.
 Packaging section.
 Finished product.
 Raw Material.

Lab Facility
Lab facility of Amico Laboratories Limited is so excellent. Their lab can be described in the
following way-
 Analytical lab
 Instrumental lab
 Microbiological lab
Quality control department serves the following functions
1. Before purchasing of raw materials QC department test the all B.P.& U.S.P specifications
of raw materials from the sending sample.

2. When raw materials are sent by the source in terms of invoice Q.C. department collects
the sample on the basis invoice & labeled an under test sticker.
3. If it meets all E.P., U.S.P., B.P. specification then a passed sticker is labeled.
4. After manufacturing of pharmaceutical preparation Q.C department collects sample from
bulk product & test its physical & chemical parameters.
5. Q.C department also tests the packaging materials & inspects its printing name
corresponding to the product.
6. Q.C department tries to recover tests the quality after final packaging.
7. If any finished product is damaged during transfer to CWH Q.C department try to recover
the product as a return goods.
8. After market complain Q.C department tests the product whether the complain is justified
or not in respect to the keeping sample.
9. Any new products or raw materials supplied by the source is tested by the Q.C
respectively for 3 batches’ & set its clear information for monitoring or keeping studies.
10. The Q.C department tests water that is used for manufacturing process as it meets its
specification.
Laboratory Equipment
According to the ICH guidelines the microbiology test of raw materials and finished product is
an important parameter of the quality drug. According the SPLU2 has a special separate
microbiology laboratory in order to carry out the microbiology tests order several sensitive
products.
The microbiology test program includes the following
 Test of raw material and packaging material.

 Test of finished product
 Environmental monitoring
 ETP water test.
Finished product Analysis for Tablet/Capsule
 Appearance
 Identification

 Average weight of tablet

 Hardness
 Thickness
 Disintegration time
 Friability test
 Dissolution
 Content uniformity
 Chemicals assay
 Life of expiry
 Related substance
Packed analysis
 Pack analysis
 Appearance (pack)
 Appearance (product)
 Leakage test
 Unit pack description
 Life of expire
List of Laboratory equipment
SL NO Name of Equipment Model Manufacturer/Supplier

01 Disintegration tester ED-2SAPO
02 Water Bath H.H.S
03 PH Meter 3510
cyber Scan 500

04 Melting poit 9100
05 UV-Spectrophotometer UV-1700 Shimadzu,Japan
Pharmaspec
06 Karl Fischer 870KF Titrino Plus
07 Moisture Analyzer MA 30 Germany
08 Magnetic steer HC501

09 Thermo lab humidity chamber

10 IR Spectrophotometer FT/IR-460 Plus JASCO-Japan
11 HPLC SPD-10AVP
12 Sonicator
13 Friability tester
Disintegration tester
Disintegration time registration of each tablet
1. USP / EP / IP compliant
2. Unique camless drive
3. Dual station with individual drive and timer
4. Magnetic coupling to the moving arm allows quick, easy and safe basket handling
5. Moulded water bath with fliptopcover
6. Built-in stirrer for precise temperature control in the water bath
7. Specially designed temperature probes for continuous monitoring of temperature in both the beakers.
8. Illumination of tablets for better visibility of the disintegration process.

Function of Disintegration Tester
This equipment is used for disintegration testing of solid item, it has functions of double circle
control systems, preset time of stop for each circle control system and beep hint, the latest
temperature control technology is used for water temperature control.
UV spectrometer
Function
It can also be used for other functions having to do with change in UV spectrum. We use it in our
lab to track the folding and unfolding of proteins, since the two conformations have different
absorbance maximums. We can tell the extent to which it folds/unfolds, and the time it takes to
do so. Microbiologists use them to measure optical density (think of it as how cloudy a solution
is) to track the growth of bacteria growing in liquid medium. The possibilities for good times are
endless )

PH meter
Function of PH meter
Glass electrodes are commonly used for pH measurements. There are also specialized ion
sensitive glass electrodes used for determination of concentration of lithium, sodium,
ammonium, and other ions. Glass electrodes have been utilized in a wide range of application -
from pure research, control of industrial processes, to analyze foods, cosmetics and comparison
of indicators of the environment and environmental regulations: a microelectrode measurements
of membrane electrical potential of a biological cell, analysis of soil acidity, etc.
Karl Fischer

Routine determinations of water with the new 870 KF Titrino plus
The favorably priced 870 KF Titrino plus is Metrohm’s new Karl Fischertitrator for volumetric
water determinations. It can be used to determinewater contents from a few ppm up to 100%
reliably and accurately insolid, liquid and gaseous samples. With its new operating interface
designedfor routine users, the 870 KF Titrino plus is so easy to operate thatit only requires a
short familiarization period. Also its robustness makes itthe ideal titrator for routine
determinations.
Moisture Analyzer
Use of moisture meter
Moisture meters are used to measure the percentage of water in a given substance. This
information can be used to determine if the material is ready for use, unexpectedly wet or dry, or
otherwise in need of further inspection.
Wood and paper products are very sensitive to their moisture content. Physical properties are
strongly affected by moisture content. Dimensioning also changes with moisture content.

IR Spectrophotometer
Uses and applications
Infrared spectroscopy is a simple and reliable technique widely used in both organic and
inorganic chemistry, in research and industry. It is used in quality control, dynamic measurement,
and monitoring applications such as the long-term unattended measurement of CO 2
concentrations in greenhouses and growth chambers by infrared gas analyzers.
It is also used in forensic analysis in both criminal and civil cases, for example in identifying
polymer degradation. It can be used in detecting how much alcohol is in the blood of a suspected
drunk driver measured as 1/10,000 g/mL = 100 μg/mL.
A useful way of analysing solid samples without the need for cutting samples uses ATR or
attenuated total reflectance spectroscopy. Using this approach, samples are pressed against the
face of a single crystal. The infrared radiation passes through the crystal and only interacts with
the sample at the interface between the two materials.
With increasing technology in computer filtering and manipulation of the results, samples in
solution can now be measured accurately (water produces a broad absorbance across the range of
interest, and thus renders the spectra unreadable without this computer treatment).
Some instruments will also automatically tell you what substance is being measured from a store
of thousands of reference spectra held in storage.
Infrared spectroscopy is also useful in measuring the degree of polymerization in polymer

manufacture. Changes in the character or quantity of a particular bond are assessed by measuring
at a specific frequency over time. Modern research instruments can take infrared measurements
across the range of interest as frequently as 32 times a second. This can be done whilst
simultaneous measurements are made using other techniques. This makes the observations of
chemical reactions and processes quicker and more accurate.

Infrared spectroscopy has also been successfully utilized in the field of semiconductor
[3]
microelectronics: for example, infrared spectroscopy can be applied to semiconductors like
silicon, gallium arsenide, gallium nitride, zinc selenide, amorphous silicon, silicon nitride, etc.
The instruments are now small, and can be transported, even for use in field trials.
High-performance liquid chromatography
High-performance liquid chromatography (sometimes referred to as high-pressure liquid

chromatography), HPLC, is a chromatographic technique that can separate a mixture of
compounds and is used in biochemistry and analytical chemistry to identify, quantify and purify
the individual components of the mixture.

Dissolution testing
In the pharmaceutical industry, drug dissolution testing is routinely used to provide critical in
vitro drug release information for both quality control purposes, i.e., to assess batch-to-batch
consistency of solid oral dosage forms such as tablets, and drug development, i.e., to predict in
vivo drug release profiles.
In vitro drug dissolution data generated from dissolution testing experiments can be related to in
vivo pharmacokinetic data by means of in vitro-in vivo correlations (IVIVC). A well established
predictive IVIVC model can be very helpful for drug formulation design and post-approval
manufacturing changes.
The main objective of developing and evaluating an IVIVC is to establish the dissolution test as
a surrogate for human bioequivalence studies, as stated by the Food and Drug Administration
(FDA). Analytical data from drug dissolution testing are sufficient in many cases to establish
safety and efficacy of a drug product without in vivo tests, following minor formulation and
manufacturing changes (Qureshi and Shabnam, 2001). Thus, the dissolution testing which is
conducted in dissolution apparatus must be able to provide accurate and reproducible results.
Several dissolution apparatuses exist. In United States Pharmacopeia (USP) General Chapter
<711> Dissolution, there are four dissolution apparatuses standardized and specified. They are:
1. USP Dissolution Apparatus 1 – Basket (37°C)
2. USP Dissolution Apparatus 2 – Paddle (37°C)
3. USP Dissolution Apparatus 3 – Reciprocating Cylinder (37°C)
4. USP Dissolution Apparatus 4 – Flow-Through Cell (37°C)
USP Dissolution Apparatus 2 is the most widely used apparatus among these four.

The performances of dissolution apparatuses are highly dependent on hydrodynamics due to the
nature of dissolution testing. The designs of the dissolution apparatuses and the ways of
operating dissolution apparatuses have huge impacts on the hydrodynamics, thus the
performances. Hydrodynamic studies in dissolution apparatuses were carried out by researchers
over the past few years with both experimental methods and numerical modeling such as
Computational Fluid Dynamics (CFD). The main target was USP Dissolution Apparatus 2.The
reason is that many researchers suspect that USP Dissolution Apparatus 2 provides inconsistent
and sometimes fault data. The hydrodynamic studies of USP Dissolution Apparatus 2 mentioned
above clearly showed that it does have intrinsic hydrodynamic issues which could result in
problems. In 2005, Professor PieroArmenante from New Jersey Institute of Technology (NJIT)
and Professor Fernando Muzzio from Rutgers University submitted a technical report to the
FDA. In this technical report, the intrinsic hydrodynamic issues with USP Dissolution Apparatus
2 based on the research findings of Armenante’s group and Muzzio’s group were discussed.
Amico laboratory limited is an attractive, protective, well organized and defined plant. Its
location design, construction, adaptation and maintains is good for the operations to minimize
risks of error and cross-contamination permit effective clearing and maintenance in order to
avoid cross contamination, build-up of dirt and dust and in general any adverse on quality of the
products.
We are enough to carry out the training without any difficulties from any side. We wish the
management if Amico laboratories limited. Family to be so helpful to us our during four weeks
training period. Here we indicate Amico laboratories limited. As a family because we found the
whole working staff and officers just like a family member which encourage their working
ability. In Amico laboratories we learn many factors which cannot be learn by reading book.
Although there are some limitations Amico laboratories is only company that never compromise
with quality. So we feel ourselves lucky to complete in-plant training in this company. We hope
that it will improve day by day with their mission and vision.
At last we wish that this company would always prove worthy to attain its ultimate goals in
promoting the country wide pharmaceutical area.

Packaging Department 55
PACKAGING DEPARTMENT
Packaging is the process by which the pharmaceutical products are suitable packed, in such way
that they should retain their therapeutic effectiveness from the time of their packaging to
consume by the consumers & it also helps to withstand the stress during transport.
Purpose of Packaging:
 To increase the acceptability of the drug.

 To increase the stability of the drug.
 To minimize the transport/shipping hazards.
 To improve patients compliance.
 To improve the pharmaceutical elegance by use of special color or contrasting printing.
Packaging’s are of two types:
1. Primary packaging (Direct contact with the product eg.alluminium foil)

2. Secondary packaging (No contact with the product eg. cartoon case etc)

Primary packaging has two categories:
1. Blister packaging
2. Strip packaging.
Material Used in Packing Section:
1. PVC/PVDC Film.
2. Alu-Alu Foil (Bottom).
3. Bottle/Alu.Tube.
4. PP Cap.
5. Label.
6. Unit Carton.
7. Insert.
8. Plastic Spoon.
9. Stopper.
10. Shipping Carton.
11. Plastic cap.
Important for primary packaging:
1. Plug area create pocket by plugging (Alu-Alu), In case of Alu-PVC forming create pocket
with the help of air pressure & temp (130º-160 ºC).
2. Tablets are manually arrang

3. ed into production trey.
4. In case of automatic filling, hopper chute channel has two parts


Chute vibrator

Feeding roller.

5. Top holders contain Aluminium foil.
6. Sealing temperature 150 ºC to 210 ºC.
7. Scoring is done by slitter. In case of alu-alu, no heat is required. Whereas in alu-PVC 80 ºC to

100 ºC temperature is required.
8. Waste coiler coil the wastage remaining after cutting.
9. Drawer draws the blistering materials to the cutting area.
The test that are performed by this section for packaging materials are-
Materials Name Test specification

PVC Color, width, thickness, weight per unit area etc.
Cotton Appearance, weight, moisture.
Shipping carton Weight, diameter, thickness.
Inner carton Height and level description.
Plastic cap Appearance, weight, length, volume etc
Dropper Appearance, length, weight and plastic cover.
Tape (adhesive) Appearance, width, Adhesiveness.
Bottles, Height, volume, capacity, diameter, machine acceptance etc.
Ampoules
Test for Primary packaging:
 Leak test
 Primary quality
 Batch No. and Exp. Date
 Perforation
 Sealing
 Clarity of Pocket
Leak Test:
Leak test is done by the leak test machine after completing blistering and stripping.
Blister / strip are kept under the pored vehicle in the container which contains purified water. Air
pressure is given by switching on. Maximum 760 mmHg pressure can be given. But usually
400mmHg is given in case of big pocket and 600mmHg is given in small pocket

Test for secondary Packaging:
1. Box, Leaflet, Strip
2. Batch No., Mfg. Date, Price
3. Color & printing of the Box
When the primary packaging is completed then the tablet or capsule containing blister or strips
are checked. And finally the strips or blisters are made ready for secondary packaging.

Product Development Department 59
PRODUCT DEVELOPMENT DEPARTMENT

Product development is the process by which a company does one of two things:

Create an entirely new product that either adds to and existing product line or occupies an
entirely new niche

Modifies or updates an existing product. Successful product development is essential for
any business if it hopes to exist for any length of time.
In Amico Laboratories Ltd. Product development department is divided into two units:
1. Product development – Formulation

2. Product development – Analysis
Activity of PD Formulation:
 Receive product proposal.

 Prepare draft recipe & send to marketing.
 Receive product brief.
 Develop final recipe & send to marketing.
 Identify raw materials/packaging materials and send to marketing.
 Quantity & Raise requisition for raw materials/packaging materials.
 Prepare specification.
 Receive of raw materials for product development.
 Prepare of packaging materials specification.
 Prepare lab batch.
 Develop and validation and rationale.
 Prepare final formulation and rationale.
 Identify aspects and impacts of the product.
 Prepare pilot batches.
 Perform initial studies.
 Put samples on storage conditions.
 Perform 01 month study.
 Receive draft design & forward to production.
 Place requisition for trial production.
 Perform 1.5 months study.
 Prepare content of shelf-life.
 Check change parts & machines performance.
 Receive final design.
 Receive new product material for trial batches

Activity of PD analysis:
1. Method development:
Method development involves the following steps:
← Define method objectives and understand the chemistry.

← Initial HPLC conditions.
← Sample preparation procedure.
← Standardization.
← Final method optimization.
2. Method validation:
The objective of validation of an analytical method is to demonstrate that the procedure,

when correctly applied, produces results that are fit for purpose.
ADMINISTRATION DEPARTMENT
Headed by the Factory Manager the Administration Department is the heart of Amico
Laboratories Limited. Security, welfare activities and the management of staff are only a few of
the Administration Department’s responsibilities.
The main function of this department is to run the plant smoothly by performing the following
functions:
1. Recruitment of personnel with appropriate qualification and experience to fill all position that
has an effect upon quality. Different standard are considered for different position.
2. Assist new employees to complete joining activities and ensure placement of new comers.
3. To arrange, induction-training program for new employees. After joining each employee is
introduced with all of the departments and their functions to know about company operation.
4. Prepare and coordinate internship program for the students of different universities.
5. Maintain & update personal files of all employees monthly. Such as conformation of job
increment, promotion, transfer and other letters is adjusted in the employee file.

6. Supervise & monitor employee monthly attendance, Job cards, prepare monthly attendance
summary and daily absent report etc.
7. Inform managers & employees regarding, personnel policies and procedure of the company.
8. Deal with industrial related issues like negotiation with employees union, ensure the labor
rights etc.
9. Ensure proper implementation of labor laws applicable to factory employees.
10. Maintain liaison with Govt. regulatory bodies.
11. Ensure safety of all employees and company assets.
12. Ensure proper security management of the plant.
13. Handle external visitor & arrange necessary uniforms & other accessories.

Products 62
Products
Brand Generic Name Pharmacolog Uses Side Dosage
Name y Effect From
septicemia, Diarrhea 250, 500 &

Ciprofloxacin
Amiflox Antimicrobials bacteremia, 750 mg Tablet
HCl,USP
peritonitis
Antimicrobials Upper Diarrhea, 500 mg Tablet
respiratory stomach & 15ml
tract infections pain Suspension
Azithromycin
Azix including
Dihydrate, USP
sinusitis,
pharyngitis and
tonsillitis
Antibiotics pneumonia, GIT
250, 500mg
ear, skin, throat disturbanc
Belocef Cephradine, BP Capsule &
and urinary es
15ml drops
tract infections
Antibiotics/ Respiratory,Ph diarrhea,
Cefaclor Antimicrobials aryngitis and nausea 250mg
Clocef
Monohydrate,USP Tonsillitis and Capsule
Infections vomiting
Antibiotics/ To reduce the dizziness,
100ml
Antimicrobials development fainting,
Erythromycin suspension
Erixin of drug- hearing
Ethylsuccinate,USP and 500mg
resistant problems
Tablet
bacteria
Antibiotics/ Upper and Stomach
Antimicrobials lower upset/pain
respiratory , diarrhea,
tract infections, nausea,
200mg
Cefixime Trihydrate, Urinary tract gas, heada
Gen-3 Capsule &
USP infections, che
Suspension
Gonococcal
urethritis,
Acute otitis
media.
Antimicrobials Anthrax, GIT
Bacterial disturbanc
Levin Levofloxacin, INN 500mg Tablet
Infection, Blad es
der Infection
Antibiotics/ Salmonellosis
Antimicrobials ,Colibacillosis
Doxycycline 100mg
Monadox ,Infectious
HCl,BP Capsule
Coryza,Chroni
c Respiratory

Products 63
Disease
(CRD),
Mycoplasmosi
s in poultry.
Antibiotics/ Acute bacterial nausea,
Antimicrobials maxillary vomiting,
sinusitis diarrhea,
Cefuroxime caused by abdominal
Lepath 250mg Tablet
Axetil,USP Streptococcus discomfort
pneumoniae, or or pain
Haemophilus may occur
influenzae
Antibiotics/ Acute otitis diarrhea,
Antimicrobials media, Acute nausea,
maxillary skin &
40mg/5ml and
Cefpodoxime sinusitis, vaginal
Leprox 80mg/5ml
Proxetil, USP Pharyngitis, fungal
Dry syrup
Tonsillitis infection,
abdominal
pain
Antibiotics/ acute and diarrhea,
Clarimycin Antimicrobials chronic nausea,vo
Clarithromycin,USP 500mg Tablet
Tablet bronchitis and mitting
pneumonia
Antibiotics/ actinobacillosis Frothing
Antimicrobials , and
actinomycosis, salivation
coccidiosis, can follow
mastitis, canine oral
erlichiasis, oral dosing in
necrobacillosis cats.
, infectious Folate 250mg &
Tetracycline
Monatrex foot rot, deficiency 500mg DS
Hydrochloride, BP
necrotic may occur Capsule
rhinitis, during
metritis, prolonged
infectious treatment
keratitis, in
infectious animals.
polyarthritis,
post abortion
Antibiotics/ Genito-urinary Nausea
Antimicrobials tract and
120mg
infections: vomiting
Dispersible
Urethritis, constitute
Tablet, 480mg
Sulphatrim Co-Trimoxazole cystitis, the bulk
960mg Tablet,
prostatitis, gastrointes
60ml, 100ml
pyelonephritis, tinal
Suspension
gonorrhoea. reactions.
Skin Diarrhoea,

Products 64
infections: glossitis,
Pyoderma, and
abscess and stomatitis
wound are
infections uncommo
n
Antibiotics/ infections due Gastro-
Antimicrobials to intestinal
Grampositive upsets
250/500mg
organisms, (e.g.
Capsule,
Monaclox - Flucloxacillin including nausea,
Drysyrup &
F Sod.,BP infections diarrhoea)
DS
caused by β- and skin
Suspension
lactamase rashes
producing
staphylococci.
Antibiotics/ Infections of Gastro-
Antimicrobials the ear, nose, intestinal 100/250/500m
and throat upsets g capsule,15
Amoxycillin genitourinary (e.g. ml Drops,
Monamox
Trihydrate,BP tract nausea, Drysyrup and
diarrhoea) DS
and skin Suspension
rashes
Antibiotics/ Bronchitis, Insomnia,
Antimicrobials Acute headache,
Bacterial vomiting
Exacerbation
of Chronic
Bronchitis,
Panflox Sparfloxacin,INN Chronic 200mg Tablet
Obstructive
Pulmonary
Disease
(COPD), Lung
abscess and all
other RTIs
Antibiotics/ tonsillitis, vomiting,
Antimicrobials pharyngitis, dizziness,
sinusitis and headache,
otitis media. pruritus,
dyspepsia, 150/300mg
Rocky Roxithromycin,BP flatulence, Tablet &
tinnitus, Suspension
vertigo
and
constipati
on
Mebendazo Antihelmintic
Mebendazole BP 100mg Tablet
le

Products 65
Antihelmintic Intestinal vomiting,

400mg Tablet
Zoben Albendazole,USP infection dizziness,
& Suspension
headache
Vitamins Diabetic a few
neuropathy ,Sc allergic
iatica, reactions
Vit-B1+ B6+ B12, Peripheral may be
Big-B Tablet
BP neuralgia. seen.
Facial
neuralgia
Vitamins/Haema improves Generally

tinic/Minerals digestion; well
promotes tolerated
healthy hair,
skin and nails,
good vision,
Multivitamin + Cod strong bones 60/100/200ml
Codvita
liver Oil and healthy Syrup
teeth; increases
resistance
against coughs,
colds, chest
and bronchial
troubles
Vitamins Glossitis, allergic
stomatitis, and
cheilosis, idiosyncra
beriberi tic
100/200ml
Flavit Vitamin B Complex polyneuritis reactions
Syrup
are
possible at
lower
levels
Vitamins/Haema especially who Well
tinic/Minerals cannot intake tolerate
supplements in
solid dosage
forms e.g.
Multivitamin + tablet and who
Flavit-M Tablet
Multimineral suffer
gastrointestinal
side effects
after taking
solid dosage
forms
Vitamins/Haema the treatment well
Iron with Folic tinic/Minerals and tolerated Capsule &
Fero-TR
Acid,BP prophylaxis of Tablet
Iron, Folic

Products 66
Acid
Vitamins/Haema Iron and Folic Gastric

tinic/Minerals acid and Zinc distress,
deficiency abdominal
Ferrous Sulphate +
Feraz cramps, Capsule
Folic acid + Zinc
diarrhoea,
allergic
reaction
Vitamins/Haema Indicated for well
tinic/Minerals the prevention tolerated
Carbonyl Iron+Folic and treatment
Feropreg Capsule
Acid+Zinc Sulphate of Iron, Folic
Acid, Zinc
deficiencies.
Haematinic/Min Prevention and nausea,
erals treatment of dark stool,
Irotrex Ferrous Sulphate iron deficiency vomiting, 200ml Syrup
anemia stomach
cramping
Vitamins/Haema treatment and nausea,
tinic/Minerals prevention of vomiting,
Iron Polymaltose + Iron, B- constipati
Irotrex- 30/50&100ml
Vitamin B complex vitamins and on or
Plus Syrup
+ Zinc Zinc diarrhoea
deficiencies may occur
Vitamins/Haema For the infant Well

15ml Ped.
Micovit Multivitamin Drops tinic/Minerals tolerated Drops
Vitamins/Haema during In rare
tinic/Minerals pregnancy and cases,
lactation, and flatulence,
in children and diarrhoea
adolescents at or
time of rapid constipati
growth, on
inadequate
Oracal Calcium Carbonate intake of 500mg Tablet
calcium in the
diet due to
malnutrition,
prevention and
treatment of
osteoporosis,
disorders of
osteogenesis

Products 67
and tooth
formation,
latent tetany
Vitamins/Haema Bone Calcium mild

tinic/Minerals Regulator gastrointes
Calcium Carbonate tinal
Oracal - M Tablet
+ Multiminerals disturbanc
es
Vitamins/Haema Treatment of mild

tinic/Minerals osteoporosis, gastro-
rickets, intestinal
osteomalacia, disturbanc
tetany and es, such as
hypoparathyroi constipati
Calcium Carbonate
Oracal - D + Vitamin D dism on, Tablet
flatulence,
nausea,
gastric
pain,
diarrhoea
Vitamins Riboflavin is diarrhea

used for
preventing low
Riboflavine Riboflavine,BP levels of Tablet
riboflavin
(riboflavin
deficiency)
Vitamins Scurvy, diarrhoea,

pregnancy, abdominal
lactation, bloating,
infection, iron over-
trauma, burns, absorption
cold exposure that is
harmful in
Suvic Vitamin C 250mg Tablet
patients
with
thalassae
mia,
sideroblast
ic anemia,
and

Products 68
haemochr
omatosis;
Vitamins/Haema treatment of well

Superantioxidant tinic/Minerals vitamin- tolerated
Synergy Vitamins with mineral Tablet
Multiminerals deficiencies
Vitamins Cardiovascular minor side

diseases, effects,
Heavy metal including
poisoning, hypertensi
Hepatotoxin on,
poisoning, fatigue,
Hemolytic diarrhea
anemia, and
Tocomin Vitamin - E Tablet
Oxygen myopathy.
therapy and
replacement
therapy in
nutritional
deficiency
states
Vitamins/Haema prophylaxis of nausea,

tinic/Minerals Iron, Folic anorexia,
Acid, Vitamin vomiting,
B-Complex, discomfort
Vitamin C and ,
Iron + Folic Acid +
Totalex Zinc + Vit-B Zinc constipati Capsule
Complex +vit-C deficiency on and
especially diarrhoea
during may occur
pregnancy and
lactation.
Vitamins/Haema vitamins and diarrhea

tinic/Minerals minerals and
Multivitamin + deficiencies. gastrointes
Vitan Multimineral (A to tinal Tablet
Z) disturbanc
es.
Multivitamin + Vitamins/Haema vitamins and diarrhea

Vitan -
Multimineral (A to minerals and Tablet
Gold
Z)

Products 69
tinic/Minerals deficiencies. gastrointes

tinal
disturbanc
es.
Vitamins/Haema treatment of hypersensi

tinic/Minerals diarrhoea, tivity to
especially for Zinc
the children
from 2 months
Zn Zinc Sulphate,USP to 5 years of 100ml Syrup
age in
connection
with Oral
Rehydration
Salts (ORS).
Vitamins/Haema Treatment and allergic

tinic/Minerals prevention of and
B-vitamins and idiosyncra
Zinc tic
Zinc Sulphate + deficiencies. reactions
Zn-B 100ml Syrup
Vitamin B Complex are
possible at
lower
levels
Vitamins/Haema Vitamin and gastrointes

tinic/Minerals mineral tinal
Kidovit Multivitamin deficiencies. intoleranc 100ml Syrup
e
Analgesic / Anti Spasm drowsines

Baclofen inflammatory ,Tension type s, nausea,
Baclofen USP 10mg Tablet
Tablet Spasmolytic headache dizziness
Analgesic / Anti osteoarthritis, dyspepsia,

inflammatory rheumatoid abdominal
Spasmolytic arthritis, pain,
ankylosing nausea
Clofenta Aceclofanec,BP spondylitis, and 100mg Tablet
dental pain, diarrhoea
post-traumatic
pain, low back
pain,

Products 70
gynaecological
pain etc
Analgesic / Anti Spasm of the dry

inflammatory gastrointestinal mouth,
Spasmolytic tract & tachycardi
genitourinary a,constipat
Hybut Hyoscine tract ion and
10mg Tablet
tablet Butylbromide BP ,Spasmotic urinary
dysmenorrheal, retention
Irritable bowel
syndrome,
Analgesic / Anti peptic ulcer Urinary

inflammatory and it prevents retention,
Spasmolytic muscle spasm Confusion
Oxyphenoium
Isonil Bromide,INN in the and 5 mg Tablet
gastrointestinal giddiness
tract
Analgesic / Anti rheumatoid Gastrointe

inflammatory arthritis, stinal
Spasmolytic ankylosing disorders
Ibuprofen spondylitis,
Ibuprofen 400mg Tablet
Tablet osteoarthritis
and other non-
rheumatoid
Analgesic / Anti osteoarthritis, · GIT

Decoxib Valdicoxib, INN inflammatory rheumatoid disorder 20mg Tablet
Spasmolytic arthritis,
Analgesic / Anti Fever, Pancreatiti

500mg Tablet
inflammatory common cold s, skin
Para Paracetamol, BP & 650mg
Spasmolytic and influenza rashes Tablet
Analgesic / Anti Fever, skin
inflammatory headache, rashes,
Spasmolytic migraine, neutropeni
muscle ache, a&
Paracetamol with 500mg +
Para-C Caffeine, BP backache, gastro- 65mg
toothache & intestinal
menstrual pain. disturbanc
es
Para-D Paracetamol with Analgesic / Anti Short-term Hypersens 325mg +

Products 71
Tramadol inflammatory management itivity of 37.5mg Tablet

Spasmolytic acute pain tramadol
Analgesic / Anti Fever, Pancreatiti

inflammatory common cold s, skin
Para-ext. Paracetamol, BP 665mg Tablet
Spasmolytic and influenza rashes
Analgesic / Anti osteoarthritis GI 50mg Tablet,

Diclofenac Sodium, inflammatory or rheumatoid disorders 100mg SR
Novarin
BP Spasmolytic arthritis Capsule &
Gel
Analgesic / Anti rheumatoid rash,
inflammatory arthritis, ringing in
Spasmolytic osteoarthritis, the ears,
ankylosing headaches
spondylitis, ,
juvenile dizziness,
rheumatoid drowsines
arthritis, acute s,
gout, acute abdominal
Naproxen Naproxen.BP 500mg Tablet
musculoskeleta pain,
l disorders, nausea,
post-operative diarrhea,
pain and constipati
dysmenorrhoea on,
heartburn,
fluid
retention
Analgesic / Anti Post-operative dizziness/

inflammatory pain,Colic and vertigo,
Spasmolytic spastic pain, nausea,
Cancer pain, headache, 500mg
Tramadol Tramadol HCl, INN
Joint pain, somnolenc Capsule
Neck and back e,
pain
Analgesic / Anti short-term , gastro-

inflammatory management of intestinal
Spasmolytic moderate to bleeding,
Ketorolac severe acute melaena,
Troy 10mg Tablet
Tromethamine USP post-operative peptic
pain ulcer,
pancreatiti
s, anxiety,

Products 72
drowsines
s
Cardiovascular all grades of upper

hypertension, respiratory
Chronic heart infection
failure, Stroke ,dizziness
risk reduction and leg
Losartan
Losaron Potassium,INN in hypertension pain 50mg Tablet
& LVH and
Nephropathy
in type 2
Diabetes
Cardiovascular Hypertension fatigue,

,Angina vivid
pectoris dreams,
,Cardiac insomnia,
arrhythmia , diarrhoea,
Myocardial constipati 50mg and
Atenolol Atenolol, BP
infarction on, 100mg Tablet
impotence
and
paraesthes
ia
Antacid / Anti- reflux Dizziness,

Ulcerants esophagitis, diarrhea,
acid reflux headache
Healer Omeprazole,BP disease, 20mg Capsule
duodenal and
benign gastric
ulcers
Antacid / Anti- Duodenal gastrointes

Ulcerants ulcer, gastric tinal
ulcers, erosive disturbanc
esophagitis, es,
Zollinger- headache, 15mg & 30mg
Lansopril Lansoprazole,INN
Ellison dizziness, Capsule
Syndrome, H. malaise,
pylori dry or
eradication sour
mouth or

Products 73
throat.
Antacid / Anti- Peptic ulcer, headache,

Ulcerants Gastro Dizziness,
esophageal diarrhea,
reflux diseases,
Pantoprazole Sod. Gastrointestina 20mg & 40mg
Panzol
Sesq,INN l (GI) bleeding Tablet
from stress or
acid peptic
diseases
Antacid / Anti- Gastroesophag headache,

Ulcerants eal Reflux diarrhea,
Disease, abdominal
Healing of pain
erosive
20mg & 40mg
Prazia Esomeprazole , USP esophagitis, Tablet
Maintenance
of healing of
erosive
esophagitis
Antacid / Anti- Peptic

Ulcerants ulcer,gastroeso
Tablet &
Magnogel Al + Mg Hydroxide phageal reflux Suspension
diseases
Antacid / Anti- Peptic

Aluminium, Ulcerants ulcer,gastroeso
Tablet &
Peptacid Magnesium,BP & phageal reflux
Suspension
Simethicon diseases
Anti-fungal & Cutaneous,

Anti-protozoals vaginal,mucos 12ml
Fefun Nystatin,BP
al infections Suspension
Anti-fungal & Fungal

Ketofun Ketoconazole,USP Anti-protozoals infection 200mg Tablet
Anti-fungal & Superficial and

Anti-protozoals systemic
50mg &
Candid Fluconazole,USP fungal 150mg Tablet
infections

Products 74
Anti-fungal & Mild to

Anti-protozoals moderate
Clostridium 400mg Tablet
Mecozol Metronidazole
difficile & Suspension
infection
Anxiolytic / Major
Sedative Anti- depression and
Nortriptyline HCl depressant childhood
Amival 10mg + nocturnal Tablet
Fluphenazine H ensuresis(bed
wetting)
Anxiolytic / Major
Sedative Anti- depression and
Nortriptyline HCl depressant childhood
Amival-F 30mg + nocturnal Tablet
Fluphenazine H ensuresis(bed
wetting)
Anxiolytic / Used as
Flupentixol 0.5mg + Sedative Anti- antipsychotic
Amilax Tablet
Melitracin 10mg depressant drug
Anxiolytic / seizures
Clonazepa 0.5mg & 2mg
Clonazepam BP Sedative Anti-
m Tablet
depressant
Anxiolytic / Anxiety,
Funam Flupentixol
Sedative Anti- insomnia, 0.5mg Tablet
Tablet Dihydrochloride, BP
depressant
Sedative Anti- insomnia,
Sedapan Diazepam,BP depressant 5mg Tablet
seizures
Midaben
Midazolam BP Sedative Anti- insomnia, 7.5mg Tablet
Tab
depressant
Anxiolytic / seizures
Relaxium Bromazipum, BP Sedative Anti- 3mg Tablet
depressant
Anti-Histamin H1receptor Tablet &
Dyzin Cetrizine HCl
Syrup
Lodin Loratadine Anti-Histamin allergies 10mg Tablet
Loratadine + Anti-Histamin allergies
Lodin -
Pseudoephedrine Tablet
Plus
HCl

Products 75
Chlorpheniramine Anti-Histamin allergies

Pheramin 4mg Tablet
Maleate,BP
Cough respiratory
Montel Expectorant / tract infection 5mg and
Montelukast INN
Tablet Antitussive / 10mg Tablet
Anti-Asthmatics
Cough respiratory
Expectorant / tract infection syrup,15mg/5
Ambrotil Ambroxol HCl, BP
Antitussive / Ml
Anti-Asthmatics
Cough bronchiectasis
Carboten Expectorant /
Carbocisteine ,BP 100ml syrup
DS Antitussive /
Anti-Asthmatics
Cough respiratory
Expectorant / tract
Dextromethorphan
Coldflu Antitussive / infection,cold 100ml syrup
Hydrobromide,BP Anti-Asthmatics ,cough
Cough Acute
Guaiphenesin +
Expectorant / respiratory
Koftex Pseudoephedrine + Antitussive / 100ml syrup
Trip tract infection
Anti-Asthmatics
Cough Acute
Guaiphenesin +
Expectorant / respiratory
Koftex - D Pseudoephedrine + Antitussive / 100ml syrup
Dex tract infection
Anti-Asthmatics
Cough respiratory
Expectorant / tract disorder
Mucola Bromohexine HCl 100ml syrup
Antitussive /
Anti-Asthmatics
Cough Asthma,acute
100ml syrup
Salbutamol Expectorant / asthma
Salbutamol and 4mg
Sulphate,BP Antitussive /
Tablet
Anti-Asthmatics
GIT Regulators / Reduce
Antiflatulent / bloating,disco
Aeropac Anti-spasmodic mfort,pain Paed. Drops,
Simethicone, USP
Paed. Drop caused by 15ml
excess gas
GIT Regulators / Constipation,h

Antiflatulent / epatic
Lactolose
Loctoz Solution,BP Anti-spasmodic encephalopath 100ml syrup
y
Drotaverin Drotaverin, INN GIT Regulators /

40mg Tablet
Tablet Tablet Antiflatulent /

Products 76
Anti-spasmodic
GIT Regulators / Upper
Antiflatulent / gastrointestinal 10mg Tablet,
Domperidone
Xepadon Anti-spasmodic motility Suspension &
Maleate,BP
disorder Drops
Topicals
Cream/Ointment
Benzyl Benzoate, Emulsion,60
Benosol BP /Gel/Lotion/Emu & 100ml
lsion
Topicals Sunburn,
Cream/Ointment eczema,
Calamine+Zinc
Calamine Oxide,BP /Gel/Lotion/Emu rashes, poison Lotion
lsion ivy
Topicals Insecticide,aca
Cream/Ointment ricide, insect
10/15/30gm
Delice Permethrin,BP /Gel/Lotion/Emu repellent Tube
lsion
Topicals Reduce skin

Cream/Ointment inflammation,
Fluocinolone 10/15/20gm
Dermidex Acetonide,BP /Gel/Lotion/Emu relieve itching Tube
lsion
Topicals Athlete’s foot,

Econazole Cream/Ointment tinea or
5/10/15/20gm
Elocon Nitrate+Triamcinolo /Gel/Lotion/Emu pityriasis
Tube
ne Aceton lsion
Topicals
Cream/Ointment
Neomycin Suphate; 5gm & 10gm
Monabacin Bacitracin BP /Gel/Lotion/Emu Tube
lsion
Topicals Bacterial
Cream/Ointment infection
Monamyci Gentamycin 5gm & 10gm
n Sulphate,BP /Gel/Lotion/Emu Tube
lsion
Topicals
Neomycin + Cream/Ointment
5gm & 10gm
Monacom Gramicidine + /Gel/Lotion/Emu
Tube
Triamcinolon lsion

Products 77
Topicals Reduce
Cream/Ointment inflammation
Diclofenac Sodium, 10gm & 20gm
Novarin BP /Gel/Lotion/Emu Tube
lsion
Topicals
Salicylic acid 3% Cream/Ointment
Saliben 5mg/10mg/1k
and Benzoic acid BP /Gel/Lotion/Emu
Ointment g Jar
6% lsion
Topicals
Cream/Ointment 5gm/10gm/20
Clotrimazo Clotrimazole, BP
/Gel/Lotion/Emu gm/30gm/1kg
le Ointm Ointment
lsion Jar
Topicals
Cream/Ointment
Fluticasone 5/10/15/20g
Flupion Propionate,BP /Gel/Lotion/Emu Tube
lsion
Anti-diabetic
Ruzmet Metformin HCl BP 500mg Tablet
Anti-diabetic
Licazide Gliclazide, BP 80mg Tablet
Anti-diabetic
Gliden Glibenclamide 5mg Tablet
Super Oral Rehydration Others
Sachet
saline Salt (ORS)
Povidone
Others 100ml/200ml/
Povidone Iodine,USP
1000ml bottle
Antiseptic Solution
Halazone
(water Halazone USP Others 7.5mg and
purified 7.5mg 15mg Tablet
Tab)
Hepadin Others
Lamivudine INN 100mg Table
Tablet
Vastin Simvastatin USP Others 10mg Tablet
Marketing Planning Department (MPD) 78
Marketing Planning Department (MPD)

They work through- market analysis, strategy develop, tactics, Implementation, controlling,
positive or negative return, Re- validation strategy.
Responsibilities-
 Preparation of strategic brand planning

 Preparation of yearly revenue and expense budget
 Complain handling regarding inputs
 Sales and prescription monitoring
 Field work
 New product launching
 Conduct training program and cycle meeting
 Participating in doctors conference
 Providing scientific inputs as per doctor queries
 Maintaining the input stock and MPD store
 Maintaining the library of books and artwork CDs.
Management Information System (MIS)
Generally two ways of performance –
 Hardware and networking

 Software
ISP (Agni network system)
Media converter
Farewell / Router
Individual PC/Server
Conclusion 79
Conclusion
Although the four weeks’ time of our training in Amico Laboratories Limited flew very
quickly,With the co-operation of the authority and all the personnel, we have learnt a great
and gathered a lot of experience which will be helpful for our future practical purposes. In
every section, the respective authority cordially received us. They initiated our curiosity and
interest regarding the relevant subjects. We are pleased with behavior of every person
involved in the factory. Thus,we have completed our training with great satisfaction and hope
that the feeling is mutual.
In plant layout of the Amico Laboratories Limited plant at Khagan, Birulia, Savar at Dhaka is
in a word, excellent. It was, no doubt, a very well planned layout that provides an optimum
use of space and ease of operation and thus contributes highly towards optimum productivity.
The plant is very well organized and the internal environment is very supportive to the
employee, which is very nice since a congenial atmosphere increases the productivity of a
company. One of the impressive things Amico Laboratories Limited is its wide range of
products and its quality. We were also very impressed with the maintenance of GMP and the
extensive documentation of all the works kept in the company, complying with the ISO
9001:2000 requirements.
Another most impressive thing about Amico Laboratories Limited is that they are trying to
commence such kind of product which is valuable and they are marketing it in lower price.
We would like to end with a note of thanks, again to Almighty Allah, and to everyone
involved, for successful completion of this training and we hope that Amico Laboratories
Limited will continue its co-operation to allow In-plant Training in future.

Amico

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In-Plant Training Report

Amico Laboratories Limited

Amico Laboratories Limited

Submission Date: 14th March, 2019

We, as the students of Department of Pharmacy of Southeast University of

My Special thanks to company adviser Dr. Saiful Isalm; Dean of faculty of

SI. No. Heading Page no

3. Production Department 8-9

4. Tablet Section 10-34

5. Capsule section 35-39

6. Quality assurance & validation 40-42

7. Quality control department 43-54

8. Packaging department 55-58

9. Product development department 59-61

10. Products 62-77

11. Marketing Planning Department 78

Name of the Company: Amico Laboratories Limited

Change of Ownership and re-operation: 1994 July

Business type: Manufacturer, Marketer and Distributor of medicine & drugs

Ownership: Private Limited Company

Managing Director: Mojibul Islam (Panna)

Chairman: Al-Haj Mockbul Hossain

Group: A sister concern of Mona Group of Industries

Factory: Khagan, Birulia, Savar at Dhaka.

Marketing Office: 22/10, Babor Road, Block:B, Shaymoli, Dhaka-1207

ISO Certicate No. : 94210, Issue No. – 1

Amico laboratories limited has now total 161 products.

Tablets (coated-film coated / uncoated)

 Approved Products Area

 Reject Products Area

 Packaging Components Area

 Area for Bulk Products

 Area for finished Goods

 Separate Sampling Area

 Empty Hard Gelatin Capsule

Different Units of Warehouse

 Storage for Packing material.

 Storage for Finished product.

 Storage for Thermo labile product (Foster/cold storage).

Flow chart of Incoming material flow

Sampling and testing by QA /QC department

Status labeled released Status labeled rejected

In-Plant Training Report On Amico Laboratories Limited

 Leveling in the container.

 QA release/ rejected materials.

 Dispensing of released/ rejected materials.

In-Plant Training Report On Amico Laboratories Limited

Fig:– Dispensing Booth

Some common terms of Ware house

In-Plant Training Report On Amico Laboratories Limited

In-Plant Training Report On Amico Laboratories Limited

Room available in Production area

To maintain GMP the following facilities are available

 PRW (purified water) supply

 HVAC (Heating Ventilation Air Conditioning) supply

In-Plant Training Report On Amico Laboratories Limited

The Production area is meanly classified into two major areas.

← Tablet (Estrogenic, Non-estrogenic)

Solid products included

In-Plant Training Report On Amico Laboratories Limited

Operation in tablet section

 A list of chemicals with corresponding specific weight is hung in dispensing unit.

 Accurate weighing of chemicals.