1) Doshi Achal Rohitkumar

Parul Institute Of Pharmacy,

Gujarat University.

Report of the ONE MONTH training : 13th may’08 - 13th june’08

CERTIFICATE
This is to certify that this is the original report as per the industrial training undergone by
us for partial fulfillment of B.Pharm as per Gujarat University, Ahmedabad, in The
Company Name : Elysium Pharmaceuticals Ltd.

Address : Post : Dabhasa, Tal : Padra,

Dist : Vadodara, Gujarat - 391 440.

India.

Phone No : (02662) - 223825 / 223295 / 221555 / 221617 / 221819

Fax No : (02662) - 223513

Email : info@elysiumpharma.com
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ELYSIUM PHARMACEUTICALS Ltd. from 13/05/2008 to 13/06/2008. We also certify
that this is an authentic report submitted by us and not duplicated or copied from any
source already available.

Dr. Rajesh K.S.

Principle,
Parul Institute of Pharmacy.

Acknowledgement

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• We are grateful to our principal sir, Dr. Rajesh K.S. and Mrs. Anveshna Bhatt for
organizing this industrial training for us.

• We are also very much thankful to,

Mr. Y.C.Patel, M.D. of elysium pharma. ltd
Mrs. Jigansha Oza, Q.A. Manger of elysium Pharma Ltd.

• They all took out time from their busy schedule to enlighten us on some very
interesting aspects of industry.
• The experience has been highly knowledgeable and helped us in understanding
pharmacy from a different perspective. It has definitely enlightened us and shown
us a part that we were unaware of.

INDEX

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1. Introduction & layout of Elusium pharmaceutical 4
2. Products List 6
3. Training schedule 10
4. Brief report on the nature of training under gone department wise 11
5. General scheme for receipt and testing of Raw material 14
6. Flow chart for the processing of Tablets/capsules 21
7. Summary 22
8. Conclusion 23

INTRODUCTION & LAYOUT

• The Company was incorporated as Elysium pharmaceuticalsLtd. in the year 1995 as a
formulation unit, situated at
• Dabhasa, 19 kms. Away from Vadodara city, Gujarat State, India. The Company
commenced its manufacturing

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• operations in the year 1997.
• The Company is promoted by Mr. Yashwant Patel in 1995. The Company is involved in
manufacturing of sterile
• formulations like Liquid and Dry Parenterals, and non-sterile formulations like Tablets,
Capsules, Liquid orals,
• Ointment, Dry Syrups etc under third party and Contract Manufacturing segment for
established Pharma
• Companies and Produces its own products Viz.drugs under Ethical segment. Elysium
is committed to maintain
• and improve the quality of manufactured products to meet customer satisfaction. The
systems and technology are
• up-graded from time to time, through continuous training & updation. The various
areas of training consist oftechnical as well as general training like quality awareness,
communication skills, attitudinal training etc.

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6
 PRODUCT LIST

Products Name Name of Active Material Form

EASYPLEX FORTE TAB Vitamin A (as Acetate) IP 5000 IU Tablet

Vitamin E Acetate IP 25 IU
Ascorbic Acid IP 100mg
Thiamine Mononitrate IP 10mg
Riboflavine IP 10mg
Oyridoxine Hydrochloride IP 3mg
Cyanocobalamin IP 5mcg
Niacinamide IP 50mg
Folic Acid IP 1mg
Calcium Pantothenate IP 12.5 mg
Zinc oxide IP equivalent to:
15mg
Elemental zinc
Cupric oxide equivalent to:
2.5mg
Elemental Copper
Sodium Selenate euivalent to :
60mcg
Elemental selenium
Manganese Chloride equivalent
1.4mg
to : Elemental manganese
Chromium chloride equivalent
65mcg
to : Elemental chromium
Excipients q s Colour : Sunset
Yellow FCF

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EASYPLEX SYR 200ml Vit A (as Palmitate) IP 8000 IU Syr
Cholecalciferol IP 100 IU
Vitamin E (As a Tocopheryl
IP 0.75mg
Acetate)Thiam. Hydrochloride
Riboflavine Phosphate Sodium IP 1.00mg
Pyridoxine Hydrochloride IP 0.5mg
Cyanocobalamin IP 0.5mcg
D-Panthenol IP 0.5mg
Nicotinamide IP 7.5mg
L-Lysine Monohydrochl. UPS 5mg
Potassium lodide IP 50mcg
Copper Sulphate 100mcg
Copper Sulphate 100mcg
Zinc Sulphate IP 22.2mg
Flavoured syrup base q s

EASYPLEX DROPS 15ml Vitamin A (as Palmitate) IP 2500 IU Drops

Vitamin E (As a Tocopheryl
IP 2.5 IU
Acetate)
Cholecalceferol IP 200 IU
Thiamine Hydrochloride
IP 1mg
Riboflavine
Sodium Phosphate IP 1.00mg
Pyridoxine Hydrochl IP 0.5mg
D-Panthenol IP 1mg
Nicotinamide IP 10mg
Ascorbic Acid IP 40mg
L-Lysine Hydrochloride UPS 10mg
Zinc Sulphate IP 13.3mg
Flavoured sorbitol base q s

Amoxicillin 1gm
ELCLAVE 1.2gm Inj
Clavulanic Acid 200mg

Amoxicillin 250mg
ELCLAVE 300gm Inj
Clavunic Acid 50mg

Amoxicillin 500mg
ELCLAVE 600gm Inj
Clavunic Acid 100mg

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ELCODIN SYR Codeine phosphate IP 10mg Syr
Sodium Citrate IP 75mg
Chlorphenramine Maleatel IP 4mg
Menthol IP 1.5mg
Alcohol IP 0.15mg
In a pleasantry flavoured
syrup base Alcohol 3 % v.v.

ELTAX 1 gm Sterile Cefotaxime Sodium IP equiv to Cefotaxime 1gm Inj

Sterile Cefotaxime Sodium IP equiv to Cefotaxime

ELTAX 250mg Inj
250mg

ELYCET TAB Levoceterizine 5mg Pseudoephedrine Hcl 120mg Tab

ELYCET TAB Aceclofenac 100mg Paracetamol 500mg Tab

Sterile Ceftriaxone Sodium UPS equivalent to Ceftrixone

ELZONE 1mg Inj
1gm

Sterile Ceftriaxone Sodium UPS equivalent to Ceftrixone

ELZONE 250mg Inj
250gm

FEEL PLUS CAP Ferrous Glycine Sulphate Cap

280mg
Zinc Sulphate
Monohydrate UPS 30mg
Folic Acid 5mcg
Selenium (as Sodium selenite)
50mg
Histidine Hydrochloride
Monohydrate BP 4mg
Lysine Hydrochloride UPS 25mg
Choline Bitatrate 50mg
Excipients q.s

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FEEL SYR Ferrous Amno Citrate IP IP 2.5mcg Syr
75mg(equivalent of 75% of
protein) Vitamin B-12
Folic Acid IP 0.5mg
Zinc Sulphate IP 35mg
Selenium (as sodium selenate) IP 25mcg
Manganese Sulphate UPS 0.25mcg
Copper Sulphate BP 25mcg
Flavoured syrupy base q.s

FRELUNG SYR Each 10ml contains : Syr

Bromhexine Hydrochl IP 8mg
IP 10mg
Dextromethorphan
Hydrobromide
Ammonium Chloride IP 100mg
(L) Mentol IP 5mg
Flavoured Syrupy base q s
Colours : Brilliant Blue FCF & Tartraxine

NOPIDOL 50 CAP Tramadol Hydrochloride 50mg Water for Injection IP q s Cap

NOPIDOL DP Tramadol 37.5mg+ Tab

Paramacetamol 325mg+
Domperidone 10mg Tab

Tramadol Hydrochloride 50mg Inj

NOPIDOL 50mg 1ml INJ
Water for Injection IP q s

Tramadol Hydrochloride 100mg Inj

NOPIDOL 100mg 2ml INJ
Water for Injection IP q s

Rabiprazole Sodium 20mg Tab

OMEL RD Tab
Domperidone 30mg

SUCRAZEN 200ml SUSP Sucralfate UPS 1gm Susp

Sucralfate USP 1gm Susp

SUCRAZEN-O 100ml SUSP
Oxetacaine BP 20mg

Sucralfate USP 7% W/w Tube

SUCRAZEN CREAM
Metronidazole IP 1% W/w

XTRAVIT CAP Alpha Lipoic Acid USP 200mg, Elcosapentaenoic Acid Cap
90mg, Docosahexaenoic Acid 60mg, Methylcobalamin

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 1500mcg, Folic Acid IP 1500mcg

TRAINING SCHEDULE

DATE DEPARTMENT CONTACT TO INCHARGE

13-5-08 to 18-5-08 Parentrals Mr. Nilesh Shah
19-5-08 Liquid Orals Mr.Bharat Patel
20-5-08 RM/PM/FPS Mr.Vipul Suthar
21-5-08 to 23-5-08 Quality Control Mr. M. M. Shah
25-5-08 to13-6-008 Quality Assurance Mr. Thakor Padhiyar
13-6-08 Report Submission to QA Ms. J. N. Oza
Manager
13-6-08 Certification Mr. Jitubhai(Administration)

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 PARENTRALS
13TH to 18th of May

Contact person: Mr. Nilesh Shah

Manufacturing Product : 1) Baralgin M 5ml inj.(Metamizol Sodium E.P.)

2) Novalgin 2ml inj. (Analgin)
3) Deriphylline (Theophyllin + Ectophyllin)
4) Lincolin (quinine HCL)

6-STOCK VIAL FILLING

WASHING SEALING AND SEALING
STERILIZATION FILLING AND

D.H.S. 8-STOCK
. FILLING
TROLLY
AND
SEALING

LEAK TANK FILTRATION

TESTING
AND
AUTOCLAVE PROCESS RAW
WASHING MATERIAL
CONTAINER DECARTING

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This unit also operates according to its own S.O.P.
The most important feature in this unit is sterility. Care is taken that each and every step
involved in the manufacturer of injectables should be free of contamination i.e
sterilization is carried out first.

Injectables prepared are Baralgin 5 ml Injection; Novalgin 2ml injection; Deriphyllin 2ml
injection

To enter into the parenteral area one has to first change clothes…there is a separate
uniform for it. One also has to disinfect him or herself with disinfectants such as dettol

First of all decartoning of ampoules takes place

After this ampoule washing takes place- 4 washings first with Air, DM water, WFI and
then Air.
Next is the process of Dry Heat Sterilization which is a 5hr cycle
- 1 hr at 100o C
- Sterilization hold time of 2 hrs at 240o C
- Cooling at room temperature for 1 ½ hrs

Apart from these processes sterilization of filtration tank (200 litres) by autoclave is also
done. Nitrogen flushing of ampoules is also done.
Then ampoule filling and sealing is done and then it goes for visual inspection and
finally labeling and packing.

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 LIQUID ORALS
19th may 08

Contact person : Mr. Bharat patel

Manufacturing Product : Combiflam suspention Syrup

AVENTIS Pharmaceuticals
(Ibuprofen and paracetamol)

Suspending agent used : veegum K

1) This also works according to a separate S.O.P

Here liquid dosage forms such as suspensions and syrups are prepared.
Eg:- Combiflam suspension and Valparin syrup

There are 2 units in this manufacturing area. In the first area syrup is prepared without
active material. The ingredients such as sugar, water ,preservatives are mixed to
prepare a syrup in a Bulk manufacturing Tank ( 2000 litres)

From the Manufacturing Tank the preparation goes for Milling (Colloid Mill).
From this it goes to the Hopper, at the same time other ingredients such as liquid
glucose and fructose and a gum previously soaked in water and stored in a holding tank
in case of suspension are added directly into the hopper
From the hopper it goes to the manufacturing unit where active material along with
flavoring and coloring agents are added and mixed thoroughly

The second Unit consists of following through which liquid preparation takes place:-

1) Mini tunnel empty bottle washing machine – Here washing of empty bottles with
DM water takes place :- 4 sprays inside and 2 sprays outside
2) Then there is an Empty Bottle Inspection unit

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 3) Filling Tank with 8 syringes ( 35 litres)
4) Block filling and sealing machine
5) Filled Bottle Inspection Unit for visual inspection
6) Labeling and Packing

RM /PM /FPS
20-5-08

Contact Person : Mr. Vipul Suthar

2) RM :- Raw Material Store

PM :- Packing Material Store
FPS :-Finished Product Store

All the above three stores work according to S.O.P (Standard Operating Procedure) and
cGMP norms are followed

a) RM-
There are various zones through which the raw material passes before it goes for
dosage form preparation. The various zones in the RMS are:-

a) Receipt Zone(Receiving Bay)

This is the first zone through which the raw material is received
GRN(Goods Receipt Note) is prepared.
Labelling (Name of RM, Date of Receipt, Quantity received , Batch No., Manufacturer’s
Name, Mfg. Date, Expiry Date etc) of RM is checked, RM is also checked for any
damages

b) Sampling Booth
Here sampling of material takes place under RLAF (Reverse Laminar Air Flow) in
presence of QC Chemist—after this RM is labeled SAMPLED
RM is stored in Under Test Area awaiting QC Release demarcated by yellow string
On Approval from QC- RM is stored under Approved Area

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If Rejected By QC- RM is stored under Rejected Area
For storing bulk liquids there is a separate store, for flavoring agents, preservatives
there is an A.C Store

c) Dispensing Area

Two dispensing zones for RM

1) Dispensing-I
-for RM of Tablets, Capsules, Liquid orals
2)Dispensing-II
-for Parenterals

Dispensing takes place after verification of Material Requisition order (MRO) given by
the production department with batch no., batch size
Material issued on FIFO basis
For dispensing of RM the dispensing person should wear proper uniform, gloves, nose
mask and proper footwear

RLAF is switched 10 mins prior to dispensing

RLAF has 3 filters –HEPA (limit 7-15 mm) , Intermediate Filter (limit 4-6 mm) and
Negative pressure (1-4 mm)
RLAF takes place in presence of QA chemist

Each zone in the stories daily checked for maintenance of proper temperature (8-25 oC)
humidity(NMT 65 %) and pressure. The stores are cleaned periodically

The S.O.P also mentions about-

• Retesting of raw material

• Handling & Disposal of rejected material
• Inventory checking
• Scrap Disposal
• Maintenance of RLAF. Balances, Cleaning Of AHU, disinfection of various areas

b) PM

(b) The Packing Material Store works in a similar manner as the RM

1) The materials stored in this store include:-

1) Primary Material (direct contact with the drug)

Eg:- PVC foils, Aluminium foils, Ampoules, Vials,Bottles

2) Secondary Material
Eg:- Cartons, tape roll, boxes, bubbling bag, thermool balls, interlocker, literature.

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 Labels are stored under lock and key

a) FPS
In the FPS the finished dosage forms packed and labelled are stored under appropriate
conditions. As and when required the materials are dispatched prior to appropriate
notification
For Export dosage forms there are various norms fulfilled by the pharmaceutical.

QUALITY CONTROLL
21-5-08 to 24-5-08

Contact Person : Mr. M. M. shah

This is a very important department in the pharmaceutical.

The various instruments used for quality control of a pharmaceutical are:

1) HPLC Unit consisting of SPD-10A Shimadzu UV vis detector, LC 10 AT VP

Shimadzu Liquid Chromatograph
2) FTIR-8400 S Shimadzu Fourier Transform Infrared Spectrophotometer
3) Karl Fischer Titrator-for determining moisture content in material
4) Chemiline Photo fluorometer
5) Tablet dissolution tester- for determining the dissolution time of tablet
6) Disintegration Tester ED-ZAL
7) Refractometer
8) Polarimeter – for determining the optical rotation
9) UV-1601 UV Visible Spectrophotometer
10)Friabilator USP- for determining surface hardness of tablets
11) Bulk Density Apparatus
12) Melting and Boiling Point Apparatus
13) Ubique- Bursting Strength Apparatus
14) pH meter and Conductivity meter
15)Brookfield Viscometer
16)Autoclave and Hot Air Ovens
17)Titration Equipments
18)Analytical balances

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 QUALITY ASSURANCE
25-5-08 to 13-6-08

Contact person : Mr. Thakor Padhiyar

Quality Assurance makes sure you are doing the right things, the right way. This
department is involved in human resource matters as well as the programming and
management of quality assurance operations in design, developing, manufacturing and
packaging of pharmaceutical products .It ensures customer satisfaction.

The works carried out are-

1) Issuance of BMR( Batch Manufacturing Record)

This is the document which consists details of each and every step right from dispensing of raw

material upto its labeling and packing. The details of each and every step is filled by

theconcerned departments and it is the responsibility of the QA chemist to check and verify

whether the various parameters of product manufacturing mentioned in the BMR are fulfilled or

not during its manufacturing at regular intervals of time.

2) Checking parameters during product manufacturing

The various parameter mentioned in the BMR are regularly checked by the QA chemist.
For Eg:
In case of tablets- parameters checked are –

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  Humidity and Temperature of various units
 Weight variation of tablets
 Friability
 Hardness
 Disintegration time
 Coating
 Leak Testing
 Labels and packing- the label should have the correct Batch Number,
Manufacturing Date, Expiry Date, Price.
a) There should not be any overprinting on the label.
b) The name of the Drug and its details should be clearly visible.
c) There should not be any empty space in the strip nor any greasing in the
strip.
d) The boxes consisting of cartons of tablets should have proper weight and
packing.

In case of ampoules Visual Inspection is the most important step. The parameters
checked in this process are:-

a. Glass particles
b. Fibre particles
c. Black particles
d. Volume
e. Shape and size of ampoule
f. Presence of any sharp edges
g. Cross labeling should not be there

In case of any of above defects in ampoulesor tablets it is rejected and is recorded and
the corrective measures are taken.If the defects found are large in number then the
whole batch is given for rechecking by the QA chemist

After the verification of all the parameters if appropriate the batch is approved by the QA
department and then it goes for sale. At the same time a control of the batch is also kept
by the QA department for future reference

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 TABLET & CAPSULE

TABLETS

Tablets manufactured are Combiflam tablets, Rantac tablets and Nimegesic tablets

The main steps involved in formulation of a tablet are:

 Dispensing and Sieving of ingredients

 Blending
 Granulation and Milling
 Drying
 Compression
 Film Coating
 Packaging

1) Dispensing is the first step in any pharmaceutical manufacturing process. Dispensing

is one of the most critical steps in pharmaceutical manufacturing; as during this step,
the weight of each ingredient in the mixture is determined according to dose.

The active material is sieved through 20 micron sieve whereas the excipients are sieved
through 60micron sieve.

2) Blending is the successful mixing of powders .The powder/granules blending are

involved at stage of pre granulation and/or post granulation stage of tablet
manufacturing. Each process of mixing has optimum mixing time and mixing speed.
It is done with the help of Octangonal Blender.

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3) Following particle size reduction and blending, the formulation may be granulated,
which provides homogeneity of drug distribution in blend.Granulation is of two types:-

a) Dry granulation
b) Wet granulation

4) Drying is a most important step in the formulation and development of

pharmaceutical product. It is important to keep the residual moisture low enough to
prevent product deterioration and ensure free flowing properties. The commonly used
dryer is Fluidized bed dryer

5) After the preparation of granules,they are compressed to get final product. The
compression is done by multi station machine

6) Coating is also performed for the following reasons:

1. Maintaining physical or chemical drug integrity

2. Enhancing product acceptance and appearance

The commonly used coatings are Sugar coating and Film coating.

7) The type of packaging will depend on the formulation of the medicine. 'Blister packs'
are a common form of packaging used for a wide variety of products.Strip packing is
another form of packing.

CAPSULES

Capsules manufactured are Hostacycline 250/500 mg.

The steps involved in capsule manufacturing are similar to tablets. First of all dispensing
and sieving of the raw materials takes place followed by mixing. Empty hard gelatin
capsule shells of size 0 are taken.

Then the mixed powder is put in an hopper attached in the capsule filling and locking
automatic machine AF 40T.

The machine also has a vaccum system (deduster) to remove the dust of powder that
spills on the machine.It also has sensors to separate empty capsule shell from the filled
ones and brushes to clean capsule that are often covered with powder.

While this process is on the necessary parameters of the capsule are checked like the
weight, locking strength etc.

Finally it goes for packing and labelling.

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22
 Summary

As a summarization, we would like to lay that the industry was truly based on
hard-work and perfection. From our perspective and from what we saw, the industry
made a genuine effort to bring out a good quality of products.
Being a small scale industry it has managed to survived through the high
competition.The instruments used and certain processes were up dated and more of
automated, it could make as much as products of its own and also serve to loan
licensees(or third party contract) of some of the most respected pharma companies
like. SANOFI-AVENTIS,ALEMBIC, ZYDUS SARABHAI , TORRENT etc.

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 Conclusion

After completing our training at ELYSIUM PHARMACEUTICALS Ltd. , we will

have to revise our thoughts about the pharmacy. Running a Pharmaceutical Industry is
not only about manufacturing drugs but it also requires technical knowledge,
management & marketing abilities and foresight.
This training proved to be very beneficial for us and it will help us in the better
understanding of our final year subjects.
Lastly, this one month training has proved to be a booster for making a good
Pharmacist from us in the future.

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