IPQC Solid D F

1
In process quality control tests

For solid dosage forms
What Do You Mean By IPQC?

INSPECTION
TESTING
IPQC is concerned with providing

accurate ,
specific, & definite descriptions of the procedures to
be employed, from, the receipt of raw materials to
the release of the finished dosage forms.
2
Powerpoint Templates
SOLID DOSAGE FORMS

1. Tablets
2. Capsules
3. Powders
Effervescent
Oral
Insufflations
Dentifrice
Dusting
4. Lozenges
TABLETS
Que: Is it easy to manufacture a tablet ?

Ans: No
Steps of Tablet Manufacturing
Weighing
Screening
Milling
Mixing
Granulation
Blending
Compression
Packaging
Labeling
Quality Checks During

Manufacturing
I.
IPQC Parameters to be
measured
Physical Parameters:
a. temp
b. time
c. particle size & texture
d. pressure mm H2O
e. weight
f. hardness
g. thickness & diameter
h. disintegration
i. dissolution ( % release)
j. friability
k. moisture content %relative humidity
II. Attributive Features:

a. visible impurities
b. color
c. elegance
d. completeness of product
f. Defects like
Excessive powder
Pieces of tab
Abrasions
Cracks, chips, swelling,
mottling, fusion of tab..etc.
Appearance of crystals on tab
or container.
g. Engraving/Embossing logo
h. Labeling & packaging
8
BMR for Tab Mfg Process

Date
Time
Operation
Dispensing
Sifting
Room
No.
Temp
C
%RH
Diff. press
(mm H2O)
23
42
2.0
48
1.8
Milling
2.0
Blending
Compression
Coating
signature
Compression Parameters
10
Parameter
Limit
Observation
Machine speed
20 rpm (15-25 rpm)
Wt. of 20 tabs
12.00g +2 (11.76-12.24g)
Theoretical weight/tab
600mg
Hardness
25Kg (20-30 Kg)
Thickness (av. of 10
tabs)
4.10mm +0.15mm (3.95 4.25mm)
Length
10mm + 0.1 mm (9.9 10.1 mm)
Width
5 mm + 0.1mm (4.9 5.1 mm)
Disintegration time
NMT 15 mins
Wt. variation
+ 3% of Av. Wt.
Friability (10 tabs)
NMT 1.0% w/w
IPQC checks frequency during

mfg.
Parameter
Frequency
11
Wt. of 20 tabs
Every hour by production and

every two hours by QA
Hardness, thickness, length,

width
Every hour by production,

every two hours by QA
Wt. variation
Every half hour by production

and every hour by QA
DT
Every half hour by production,

every hour by QA
CAPSULES
12
Steps of Capsule Manufacturing

Mfg of Gelatin Shell.
Drying of shells in controlled humidity.
Mfg of granules/spanzules.
Filling of Shells.
Packaging & Labeling.
13
IPQC Checks During Gelatin Shell

Manufacturing
14
% purity of gelatin
Viscosity of gelatin solution 25-45 millipoise
Bloom strength of gelatin solution 150-250 gm
Iron content NMT 15 ppm
pH of gelatin A=9; B=4.7
Film Thickness
Color, surface, appearance of empty shells
Temperature of hot air, for drying of shells
Length of Capsule & Body of the shell
Moisture content 12-15%
Sorting of defective shells

After the capsules have been inspected either
electronically or manually, they are sampled by
the
QA inspector & checked for the defects and
then
sorted out.
Printing inspection on shell
15
. Inspection of defects like: Hardening of shells

Softening of shells
Swelling of shells
Cracking of shells
Discoloration of shells
Misprinting of logo on shells
IPQC Checks During Filling of Empty

Capsule Shells
During filling process equipment should be labeled
with :-product name, Batch No, Time of starting,
Sign
During Filling: flow property of granules or
powders
Weight Variation :
For hard gel capsLimit NMT 2 caps should deviate from avg wt.
16
AVG WT
%DEVIATION
<300mg
10%
>300mg or more
7.5%
For soft gel caps:

Wg 10 caps
Remove inner content by cutting with
scissor/blade
Wash with solvent & evaporate solvent at room
temperature for 30 min
Wg the empty shells & calculate % deviation
MACHINE OUTPUT INSPECTION:
17
Machine output is monitored in a specific time

interval
Total batch or number of caps filled are counted in a
specific time interval & then machine is calibrated
and
speed is maintained.
APPEARANCE:
Inspection of capsules checked with a standard strip
SORTING DEFECTS:
Electronic automated or manual inspection is made
to sort out & reject the defected caps.
Overprinting
PRINTING & LABELING:

Inspection of overprinting, logo, labeling are
checked with the standard shade cards.
Defective ones are sorted out & rejected.
18
LOZENGES
Que- Are they different from Tablets?

Ans- Yes..
19
Steps For Manufacturing of

Lozenges
Weighing
Mixing
Sifting
Granulation
Moulding/Compression at low pressure
Packaging & Labeling
20
IPQC Checks During Manufacturing

Visual inspection
Shape, size, color
Weight variation
Overprinting logo
Uniformity
Disintegration
Packaging & Labeling
21
POWDERS
22
Types of
Powders
Effervescent powders
Dusting powders
Insufflations (Inhalers)
Dentifrice
Oral powders
23
Flow Chart of Powder

Manufacturing
24
IPQC Checks During Powder

Manufacturing
25
Particle size & shape

Texture
Powder flow
Fluffiness
Density
Foreign Impurities
Moisture
Packaging
- sealing, printing
1. Effervescent Powders:
sample powder in 250ml of water
produces
effervescence & dissolves in 12sec.
2. Dusting Powder:
color, texture, density, particle size,
flow, fluffiness, spread ability
3. Insufflations:
flow, particle size, density
4. Dentifrice:
abrasion, texture, particle size, color
26
Powder Flow & Texture

Analyzer
27
Powder Flow Analyzer used to

measure:
28
Flow
Texture
Caking
Cohesion
Flow Speed
Granule attrition
Compaction & Relaxation
Dusting
Surface Friction
Aggregation
Air-entrapment
Granulation
Parameters Measured:
(principle-slicing, shearing, compaction)
speed of rotor blade
blade angle
path of blade
resistance in speed and angle
axial force
time distance travelled
Measured by a sensitive transducer attached to rotor
blades.
29
Summary
30
In-process control not only provides a means of controlling

production, it also performs a quality assurance function.
Oral Solid dosage forms are some of the most popular and
convenient methods of drug delivery.
With the high volume of products produced in these dosage

forms, it is important that the unit operations for their
production be thoroughly understood, developed and
implemented.
This presentation focuses on the fundamentals of each

discrete processing step (unit operation) with extensive
discussions on the current technologies required for the
manufacturing and packaging of solid dosage form.
REFERENCES:
1. WHO Guidelines For Good Manufacturing
Practices
2. Guidance For Industry: Nonsterile Dosage Forms; US
Dept. of health & human services
3. Manohar A Potdar; current-Good Manufacturing
Practices, Edn-2003.
4. D.H.Shah; standard operating procedures.
5. Satish Maliya; WHO Guidelines; Issue-Jan-1922;2011.
6. WHO public inspection report of finished product
manufacturing
31
32
THA
NK
YOU

IPQC Solid D F

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1

In process quality control tests

What Do You Mean By IPQC?

IPQC is concerned with providing

SOLID DOSAGE FORMS

Que: Is it easy to manufacture a tablet ?

Steps of Tablet Manufacturing

Quality Checks During

II. Attributive Features:

BMR for Tab Mfg Process

20 rpm (15-25 rpm)

25Kg (20-30 Kg)

4.10mm +0.15mm (3.95 4.25mm)

10mm + 0.1 mm (9.9 10.1 mm)

5 mm + 0.1mm (4.9 5.1 mm)

Friability (10 tabs)

NMT 1.0% w/w

IPQC checks frequency during

Every hour by production and

Hardness, thickness, length,

Every hour by production,

Every half hour by production

Every half hour by production,

Steps of Capsule Manufacturing

IPQC Checks During Gelatin Shell

Sorting of defective shells

. Inspection of defects like: Hardening of shells

IPQC Checks During Filling of Empty

For soft gel caps:

Machine output is monitored in a specific time

PRINTING & LABELING:

Que- Are they different from Tablets?

Steps For Manufacturing of

IPQC Checks During Manufacturing

Flow Chart of Powder

IPQC Checks During Powder

Particle size & shape

Powder Flow & Texture

Powder Flow Analyzer used to

In-process control not only provides a means of controlling

With the high volume of products produced in these dosage

This presentation focuses on the fundamentals of each

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