2. DOMAIN – 10
QUALITY CONTROL AND QUALITY
ASSURANCE IN PHARMACEUTICALS
Structure and Contents For
PRACTICE SCHOOL (706PS)
B. Pharm Final Year (SEM VII)
3. A Review Article By:
Shraddha Dnyaneshwar Jadhav
Final Year B. Pharmacy
PRN No. 2052811823018
Guided By:
Prof. Unmesh G. Bhamare Sir
4. Content
Introduction
Quality Control
Quality Assurance
Good Manufacturing Practices
Good Laboratory practices
ICH Guidelines
In Process Quality Control
Regulatory Authorities
Instruments
Validation
Quality by Design
Intellectual Property Rights
Conclusion
Bibliography
4
5. ABSTRACT
Quality control (QC) is a procedure or set of procedures intended to ensure
that a manufactured product or performed service adheres to a defined set of
quality criteria or meets the requirements of the client or customer.
QC is similar to, but not identical with, quality assurance (QA)There are various
quality control parameters and guidelines which ensure us to deliver slandered
and contamination free product in the market.
5
6. Introduction
Quality control in the Pharmaceutical Industry is to test the drugs in their
various stages of production, verifying that they are able to proceed to the
next stage and release the manufacturing process in accordance with the
regulations and specifications required for consumption.
The purpose of pharmaceutical quality assurance is to ensure that the
medication being manufactured will provide the desired effect to the patient.
6
7. Quality Control
The term quality control refers to the sum of procedures undertaken to ensure the
identity and purity of a particular pharmaceutical product.[1]
7
8. Quality Assurance
Quality Assurance (QA) activities include a planned system of review
procedures conducted by personnel not directly involved in the
inventory development process.[1]
8
9. QC Activities
Sampling for testing purpose(physical, chemical, biological tests)
Storing, keeping samples from each batch produced.
Maintaining batch wise quality control test records.
Ensuring precision and accuracy of all testing methods.
Calibration and standardization of laboratory equipment.
Testing of return goods.
In-process quality control tests and activities.[2]
9
10. QA Activities
Ensuring fulfillment of regulatory requirements
Monitoring the system to ensure implementation of GMP and GLP in routine
operation
Establishing manufacturing methods and SOP’s with their regular updates
Arranging quality audits
Review of market complaint
Ensuring adequate training program [2]
10
11. Good Manufacturing Practices(GMP)
Good Manufacturing practices is collectively termed as
pharmaceutical regulations, directions and guidance which a
manufacturer must follow when making medications.
11
12. Good Laboratory Practices(GLP)
Good Laboratory Practices is
a quality system concerned
with the organizational
process and the conditions
under which a study is
planned, performed ,
monitored, recorded,
archived and reported.
Elements
of GLP
QA
Documen
tation
and
Records
Certifica
tion of
Analysis
Instrume
ntation
validatio
n
12
13. ICH Guidelines
The International Conference on
Harmonization of technical requirements
for registration of pharmaceuticals for
human use (ICH) is a special project that
gathers the regulatory authorities of
Europe, Japan and the United States and
experts from the pharmaceutical
industry in the three different regions to
discuss scientific and technical aspects
of product registration.[3] ICH
Quality
Guidelin
es
Safety
Guiidelin
es
Efficacy
Guideline
s
Multidisci
plinary
Guidelin
es
13
14. In Process Quality Control (IPQC)
These are checks that are carried out before the manufacturing
process is completed. The function of of in-process controls is
monitoring and if necessary adaption of the manufacturing
process in order to comply with the Specifications.[3]
14
15. IPQC Tests for various Dosage forms
Tablets:
a) Drug contents determination
b) Moisture contents of granules
c) Assay of active ingredients
d) Weight variation of uncoated
tablets
e) Hardness test
f) Disintegration test
Syrup and Suspension:
A) Drug contents determination.
b) Assay of active ingredients.
c) pH
d) Weight per ml.
e) particle size
15
16. Test for semi-solids:
a) Drug contents determination.
b) Assay of active ingredients.
c) Uniformity test
d) Viscosity and specific gravity test
e) Filling test
Tests for injectables :
a) Drug contents determination
b) Clarity test
c) pH
d) Pyrogen test
e) Stability test
f) Leakage test
g) Check up of particulate matters
16
18. FDA
The Food and Drug Administration (FDA) is responsible for protecting the
public health by ensuring the safety, efficacy, and security of human and
veterinary drugs, biological products, medical devices, the Nation’s food supply,
cosmetics, and products that emit radiation
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19. WHO
World health organization (WHO) provides the GMP guidelines for
pharmaceuticals. These guidelines are followed through out the world. These
guidelines cover all the pharmaceutical topics as: Process validation.
19
20. MHRA
The Medicines and Healthcare products Regulatory Agency is an
executive agency of the Department of Health and Social Care in the
United Kingdom which is responsible for ensuring that medicines and
medical devices work and are acceptably safe.[5]
20
21. TGA
The Therapeutic Goods Administration is the medicine and
therapeutic regulatory agency of the Australian Government. As part
of the Department of Health, the TGA regulates the quality, supply
and advertising of medicines, pathology devices, medical devices,
blood products and most other therapeutics.
21
22. Instruments
Thin Layer Chromatography:
Thin-layer chromatography is a chromatography technique used to separate non-
volatile mixtures. Thin-layer chromatography is performed on a sheet of an inert
substrate such as glass, plastic, or aluminium foil, which is coated with a thin layer of
adsorbent material, usually silica gel, aluminium oxide, or cellulose.[6]
22
24. HPLC
High-performance liquid chromatography (or High pressure liquid chromatography, (HPLC)
is a specific form of column chromatography generally used in biochemistry and analysis to
separate, identify, and quantify the active compounds.
24
25. Dissolution Test Apparatus
Dissolution is the process by which a solid solute enters a solution.
Dissolution testing is an official test used by pharmacopeia’s for evaluating drug release of
solid and semisolid dosage forms.
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26. pH Meter
pH meters are widely used to measure the pH of water, solutions and
environmental samples.
26
27. Validation
Validation is the procedure which authorizing
documentary evidences that prove, the
following process/ method or activity will
consistently produce the product which leads
to the expected result (predetermined
requirements).
Validation
Equipment Validation
Process Validation
Method Validation
Cleaning Validation
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28. Calibration
Calibration determines that a device or instrument is producing
accurate results within the specified limits compared to those
produced by a traceable standard.
28
29. Qualification
Qualification is as an action of providing that equipment or ancillary
systems are properly installed, work correctly, and actually lead to the
expected results.
DQ
• Design
Qualification
IQ
• Installation
Qualification
OQ
• Operational
Qualification
PQ
• Performance
Qualification
29
30. Quality by Design
Quality by design is an approach that aims to ensure the quality of
medicines by employing statistical, analytical and risk-management
methodology in the design, development and manufacturing of
medicines.[7]
30
31. Steps involved in QBD:
1.Development of new molecular entity:
•Preclinical study
•Clinical study
•Submission for market approval
2. Manufacturing:
•Quality control
•Analytical technology
3. Control Strategy:
•Continuous improvement
• Product performance[4]
31
32. Process Analytical Technology (PAT)
PAT is a toolkit used to increase
operational efficiencies,
operational utilization and
process understanding, while
decreasing operation operating
expenses and ensuring that
quality is built into the
product.[9]
PAT
Industrial
Applicatio
n
Blending
Process
Analysis
of
product
Apparatu
s
Cleaning
Tablet /
Capsule
Manufact
uring
Raw
material
dispensin
g
Drying
Process
32
33. Intellectual Property Rights
Trade mark –
Sign, design that identifies the product or services from a particular source.
Copyright –
Protection against the potential infringement of the drug
discovery and development.
Patent –
Provides pharma companies exclusive rights to market drugs
and prevent others to manufacture, sell and make these drugs for
a period of 20 years.
33
34. Conclusion
As a conclusion on the entire discussion it clearly shows that quality
assurance is somehow related to all the departments in a
pharmaceutical industry, and it plays an important role in each
department to enhance the process of that particular department. As
how the title mentions that the quality assurance plays vital role and
it is said as the backbone of a pharmaceutical industry.
34
35. Bibliography
1. Handbook of International Auditing, Assurance, and Ethics
Pronouncements, International Federation of Accountants, March
2008
2. Quality Assurance in Financial Auditing, A Handbook, IDI-ASOSAI,
2009
3. Kate Davies, Bristol-Myers Squibb : The Role of QC in the
Pharmaceutical Industry
4. WHO guidelines on good manufacturing practices (2011)
5. Committee on Specifications for Pharmaceutical Preparations.
Good Manufacturing Practices for Pharmaceutical Products.WHO
Technical Report Seriesno.82.geneva: World Health Organization,
1992, pp 14-79.
35
36. 6. Rodionova, O. Y., Sokovikov, Y. V., & Pomerantsev, A. L. Quality
control of packed raw materials in pharmaceutical industry.
analytica chimica acta, 2009; 642(1): 222-227.
7. Quality Assurance of Pharmaceuticals; Good Manufacturing
Practices and Inspection, Volume – 2, World Heaith Organization,
Geneva, 1999.
8. Book: MHRA. 2017. Rules and Guidance for Pharmaceutical
Manufacturers and Distributors, London Pharmaceutical Press,
Chapter 2 EU Guidance on Good Manufacturing Practice.
9. Callis JB, Illman DL, Kowalski BR, Process analytical chemistry.
Analytical Chemistry, 59, 1987, 624A–637A.
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