It gives explanation regarding basic concepts of QC and QA.

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