IPQC and FPQC for tablets

1. IPQC AND FPQC FORTABLETS
PREPARED BY:SAKSHI ASHOK GAIKWAD
ROLL NO: QA 07
FIRST YEAR M.PHARM
(QUALITY ASSURANCE)
SEMESTER 1
GUIDED BY: PROF. MUKESH PATIL.
SHRI. D. D.VISPUTE COLLEGE OF PHARMACY
AND RESEARCH CENTRE, PANVEL.
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2. CONTENTS
1. Introduction
2. In process quality control
3. Finish product quality control
4. Objectives
5. IPQC & FPQC test:
a) size and shape
b) colour and odour
c) Unique identification marking
d) thickness
e) Hardness
f) Friability
g) Weight variation
h) Content uniformity
i) Content of active ingredients
j) Disintegration test
k) Dissolution test
6. Conclusion
7. References
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QUALITY
 Quality is a broad term which includes suitability of drugs and
products for their utilization which is decided by their efficiency
and safety, according to label claim, or as promoted or
publicized, their conformity to specifications about identity, purity
and other characteristics.
 The quality of any product must be built during plant
construction, product research and development, purchasing of
materials, production, testing, inspection, labelling, storage and
distribution.

4. QUALITY CONTROL
■ The International Standard of Organization (ISO) definition states
that quality control is “the operational techniques and activities that
are used to fulfil requirements for quality.
■ It is a part of GMP
■ To eliminate errors and production of end product of given
specifications
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IN PROCESS QUALITY CONTROL (IPQC)
FINISHED PRODUCT QUALITY CONTROL (FPQC)

5. IN PROCESS QUALITY CONTROL (IPQC)
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 The function of in-process quality controls is to monitor and if
necessary, adaptation of the manufacturing process in order to
comply with the specification
 Be carried out before the manufacturing process is completed
 Physical parameters and its quality attributes
 Involve control of equipment and environment too

6. FINISHED PRODUCT QUALITY CONTROL (FPQC)
■ These are the test carried out after completion of product
manufacturing process
■ Qualitative and quantitative analysis of product
■ Determines the test procedures and acceptance limit
■ The product must comply with the acceptance limit for the approval of
complete batch manufactured.
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7. OBJECTIVES
■ Monitor all the features of product that contributes to the
quality
■ Prevent errors
■ Provide product as per specifications
■ Identify or detect any error
■ Rectify error
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8. IPQC and FPQC tests:
■ Particle size
■ Loss on drying
■ Colour
■ Compactness
■ Integrity
■ Temperature
■ Assay
■ Uniformity of content
■ Uniformity of mass
■ Weight variation
■ Friability test
■ Content of active
ingredients
■ Hardness test
■ Disintegration test
■ Dissolution test
■ Moisture content
■ Hardness
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9. SIZE AND SHAPE
according to need of the dose requirement and can be dimensionally describe,
monitored and controlled.
It is determined by the tooling during the compression processes
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10. COLOUR AND ODOUR
To mask the original characteristics for consumer acceptance
Uniformity
The taste is the important factor when is comes to chewable tablets while odor
in vitamins.
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11. UNIQUE IDENTIFICATION MARKING
Embossing, engraving or printing
Mainly for Identification purpose
Eg. Company name or product code or specific symbol on it
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12. THICKNESS
Dimensional variable related to the process
A single tablet dimensions are measured and this is done for the whole batch
It should in between -5 and +5 mm or standard dimensions
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VERNIER CALIPER

13. HARDNESS
The resistance of the tablet to chipping, abrasion, or breakage under conditions of
storage, transportation, and handling, before usage, depends on its hardness.
Hardness is affected by- compression of tablet and compressive force
-method of granulation.
Limits -
5 kilograms minimum and 8 kilograms maximum.
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Monsanto type hardness tester

14. FRIABILITY
This property is related to hardness of tablets.
Friability =
𝐼𝑊−𝐹𝑊
𝐼𝑊
× 100
where, Iw = Total Initial weight of tablets
Fw = Total final weight of tablets.
As stated by USP if conventional compressed tablets that loss less than 0.5 % to
1 % (after 100 revolutions) of their weight are generally considered acceptable
Roche friabilator
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15. WEIGHT VARIATION
Difference in weight of tablets in a batch is measured
Average Weight (mg) Percentage Deviation (%)
130 or Less 10
130 – 324 7.5
More than 324 5
The above table is as per USP
CONTENT UNIFORMITY
This helps to understand the consistency of active pharmaceutical ingredients in
the tablets
This gives potential for efficacy of tablet in a batch and from batch to batch
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16. CONTENT OF ACTIVE INGREDIENTS
The content of active ingredients can be determine by the assay procedure
Weight of Active Ingredients in Each
Tablet
Subtract from Lower Limit for Samples
of
Add to the Upper Limit for Samples of
15 10 5 15 10 5
0.12 g or less 0.2 0.7 1.6 0.3 0.8 1.8
More than 0.12 g But less than 0.3 g 0.2 0.5 1.2 0.3 0.6 1.5
0.3 g or more 0.1 0.2 0.2 0.2 0.4 1.0
The above table is as per I.P. limits
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17. DISINTEGRATION TEST
The disintegration test is used to show how quickly the tablet breaks down into
smaller particles, allowing for a greater surface area and availability of the drug
when taken by a patient
DISINTEGRATION TEST APPARATUS
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18. Categories of Tablets Disintegration Time (min)
Uncoated tablets 15
Coated tablets 60
Effervescent tablets 5
Soluble tablets 3
Dispersible tablets 3
Orodispersible tablets 3
Gastro-resistant tablets 60
Oral lyophilizates 3
Categories of Tablets Disintegration Time (min)
Uncoated tablets 15
Coated tablets 60
Enteric coated tablets 60
Film coated tablets 30
Effervescent tablets 5
soluble tablets 3
dispersible tablets 3
BP limits for disintegration times of tablets IP limits for disintegration times of tablets
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19. DISSOLUTION TEST
Dissolution testing measures the extent and rate of solution formation from a
dosage form
The dissolution of a drug is important for its bioavailability and therapeutic
effectiveness.
In dissolution solid mass is transfer in liquid medium that is it is aqueous solubility
dependent process
More the aqueous solubility more is the dissolution rate
Dissolution test is based on following processes-
1. wetting
2. Solubility
3. Swelling
4. Diffusion
DISSOLUTIONTEST APPARATUS
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20. USP apparatus Description of the apparatus Rotation speed Dosage forms to be tested
I. basket 50- 120rpm Immediate release tablets
Delayed release tablets
Extended release tablets
II Paddle 25-50 rpm Immediate release tablets
Delayed release tablets
Extended release tablets
III Reciprocating cylinder 635 dpm Immediate release tablets
Extended release tablets
IV flow-through cell N/A Extended release tablets
Poorly soluble drug
V paddle over disk 25-50 rpm Transdermal
VI cylinder N/A Transdermal
VII reciprocating holder 30 rpm Extended release tablets
ABOVE TABLE IS AS PER USP
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21. STAGE NO. OF TABLETS ACCEPTANCE CRITERIA
S1 6 Each unit is not Q + 5 %
S2 6 Average of 12 units (S1+ S2) is equal to or
greater than Q, and no unit is less than Q-
15%
S3 12 Average of 24 units (S1+ S2+ S3) is equal to
or greater than Q, not more than 2 units are
less than Q-15% and no unit is less than
Q25%
ACCEPTANCE CRITERIA FOR DISSOLUTION OF TEST TABLETS
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22. CONCLUSION
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Standard operating procedures must be established and followed to compare
the quality of the product formed.
All the materials should be tested during and after the manufacturing process
to control the quality of the product.
In process and finished product test are carried out so as we get early
warning of any error in the product and can be rectified soon

23. REFERANCES:
Comparative study of in-process and finished products quality control test for tablet and capsules
according to pharmacopoeias: Asian Journal of Pharmaceutical Research and Development. 2018;
6(3): 60-68
L Lachman, HA Lieberman, JL Kanig. The Theory and Practice of Industrial Pharmacy, 3rd Edition,
Lea & Febiger, Philadelphia, 1986, 296-300
Unites States Pharmacopoeia Convention. United States Pharmacopoeia 31-National Formulary 33,
Stationery Office, USA, 2010.
Indian Pharmacopoeia Commission. Indian Pharmacopoeia, volume 1, Indian Pharmacopoeia
Commission, Ghaziabad, 2007
In-Process and Finished Products Quality Control Tests for Sterile and Non Sterile Dosage Form: Int.
J. Pharm. Sci. Rev. Res., 45(1), July - August 2017; Article No. 40, Pages: 206-214
Sagar Kishor Savale. / Asian Journal of Phytomedicine and Clinical Research. 6(1), 2018, 44-54.
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