This document discusses quality control and quality assurance in the pharmaceutical industry. It defines key terms like quality assurance, quality control, good manufacturing practices, and outlines the primary functions and elements of quality assurance. Quality assurance aims to ensure pharmaceutical products are of the required quality for their intended use through organized efforts ranging from research and development to post-production activities. It involves monitoring manufacturing processes, facilities, equipment, personnel and documentation.

1. Quality Control & Quality
Assurance
Presentation by
Miss Utkarsha Sukhdev Shivsharan
M.Pharm (Quality Assurance)
Assistant Professor
DSTSM’s College of Pharmacy, Solapur

2. Quality Assurance
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 A process, not an end-point
 Must ensure that quality policies are followed
 Must have final authority in product acceptance,
rejection and release to public
 Integral to production, not an add-on
 Responsible for day-to-day operations and for
longer term goal settings
 Quantitative discipline with specified parameters

3. DEFINITIONS
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 GOOD MANUFACTURING PRACTICE (GMP)
 That part of QA which ensures that products are
consistently produced and controlled to the quality
standards appropriate to their intended use.
 QUALITY CONTROL
 That part of GMP which is concerned with sampling,
specifications and testing.

4. Quality relationships
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QA
GMP
QC

5. Quality relationships
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Quality Management
Quality Assurance
GMP
Quality Control

6. DEFINITIONS
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 QUALITY
 The totality of features and characteristics of a medicinal
product and its ability to satisfy stated and/or implied needs
 QUALITY ASSURANCE
 The sum total of the organized arrangements made with
the object of ensuring that medicinal products are of the
quality required for their intended use.

7. Quality Assurance
 Quality of Product:
- Identity:
1. Who?
2. When?
3. Where?
4. How?
5. What?
6. Why?

8. • Strength:
• Safety:
-No desired effects
-Partial desired effects
-Unexpected, undesired effects
-Expected undesired effects
- Desired effects
• Purity:
(Efficacy)

9. All matters ranging effect:
1. Preproduction
2. Production & QC activities
3. Post production Activities
Ultimate User:
Sum Total of organised efforts:

10. Quality Assurance
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Primary Functions
 Quality Control
 Analytical testing of products
 Active and Non active material control
 Sampling, inspecting and testing of incoming raw materials
 Packaging and labeling components
 Bottles, caps, foils, labels, measures, cartons
 Physical inspection of product and operations at critical
intermediate stages
 In-process controls, HHACCP
 Control of product through its distribution
 GSP, GDP ETC

11. Quality Must Be Designed Into A
Product
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 Quality is not an add-on: it begins with research
and development
 Product quality criteria must be established
 Detailed specifications provide quantitative
parameters for measurement
 Written procedures document how quality is
attained and maintained
 Continuous monitoring (sampling, testing) to
confirm quality is being built-into product

12. Elements of the Quality Assurance Cycle
in Pharmaceutical Manufacturing
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 Research
 Development
 Prototyping
 Documentation
 Raw Materials
 Facilities
 Equipment
 Personnel and Supervision
 Monitoring, Feedback, Follow-up

13. Quality Control & Analysis
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 Qualification
 Design, Installation, Process and Operational
 Calibration
 Daily and periodic
 Validation
 Equipment, Method and process
 SOPs
 Authorized, used and updated
 Documentation
 Systematic and well kept
 Quality Manual
 Quality manager, staff trained and motivated to comply.
 Safety measures

14. Quality Assurance Throughout
the Manufacturing Process
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 Monitoring environmental conditions under
which products are manufactured/stored
 Monitoring of air and water systems to prevent
contamination– Air Handling Units
 Monitoring of humidity
 Monitoring of personnel
 Feedback and follow-up

15. Manufacturing Process and
Procedures
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 Dispensing / Weighing
 Mixing / Granulation / Preparation
 Compression / Encapsulation / Filling
 Equipment, Operational & Process Qualification
 Validation & calibration
 Documentation and record keeping
 Yield Reconciliation

16. A Guiding Philosophy for Quality Assurance in the
Pharmaceutical Industry
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Poor Quality Medicines:
 Are a health hazard
 Waste money for governments and consumers
 May contain toxic substances that have unpredictable,
unintended consequences
 Will not have a desired therapeutic effect
 Does not save anyone any money in the long term
 Hurt everyone – patients, health care workers, policy
makers, regulators, manufacturers

17. What is GMP? (WHO)
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 Comprehensive system for ensuring products
are consistently produced and controlled
according to quality standards
 Designed to minimize risks involved in any
pharmaceutical production that cannot be
eliminated through testing of final product
alone
 Cross-contamination

18. Major Risks in Pharmaceutical
Production
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 Contamination of products (microbial,
particulate or other)
 Incorrect labels on containers
 Insufficient active ingredient
 Excess active ingredient
 Poor quality raw materials
 Poor formulation practices