1. QUALITY ASSURANCE AND QUALITY CONTROL IN GENERICS

2. OUTLINE OF THE PRESENTATION
Introduction, Definitions and Quality Assurance and Quality control in Pharmaceutical generics
Good Manufacturing Practices
Product Selection
Suppliers and Manufacturers
Selection and Sourcing
Procedures for Prequalification of Suppliers
Stability and Equivalence
Steps in Quality Control
Cost of Quality Control
Conclusion

3. OBJECTIVES
Explain the need for a systematic quality assurance and quality control process for pharmaceutical products (in generics)
Describe key elements of the quality assurance and quality control process for pharmaceuticals (in generics)
Discuss the procedures and standards for prequalification of suppliers of pharmaceuticals
Apply quality assurance and supplier selection principles for vendors.
The main responsibilities of quality control in pharmaceutical industry include: Efficacy, Safety, Quality, Compliance.

4. QUALITY ASSURANCE AND QUALITY CONTROL
ATTRIBUTE
QUALITY ASURANCE
QUALITY CONTROL
Definition
QA is a set of activities for ensuring quality in the processes by which products are developed
QC is a set of activities for ensuring quality in products. The activities focus on identifying defect in the actual products produced
Focus
QA aims to prevent with a focus on the process used to make the product. It is a proactive quality process
QC aims to identify defects in the finished product. Quality control, therefore, is a reactive process.
Goals
The goals of QA is to improve development and test process so that defects do not arise when the product is being developed
The goal of QC is to identify defects after a product is developed and before its released
As a tool
QA is a managerial tool
QA is company based
QC is a corrective tool
QC is lab based

5. DEFINITIONS 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 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.
QUALITY CONTROL
Quality control(QC) is concerned with sampling, specifications, testing's, organization, documentation and release procedures which ensures that necessary and relevant tests are actually carried out and that materials are not released for sale, supply until their quality has been judged to be satisfactory.

6. QUALITY ASSURANCE A process, not an end-point
Must be independent of financial pressures
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

7. QUALITY CONTROL
Quality control is concerned with the operational activities and techniques that are used to fulfil the requirements of quality
The quality control process includes the activities which ensure a high quality product.
Quality control activities focus on identifying defects in the actual product being produced.
Quality control is a product based approach and used to verify the quality of the product.

8. QUALITY RELATIONSHIPS
Quality Management
Quality Assurance
GMP
Quality Control
GMP QC QA 8

9. QUALITY ASSURANCE: ESSENTIAL AT ALL STAGES

10. FACTORS IN DRUG QUALITY ASSURANCE
IMPORT
& EXPORT
CONTROL
LEGISLATIVE
FRAMEWORK
-REGULATIONS
PACKAGING
HUMAN
RESOURCES-
PROFESSIONALS
LABELLING &
PRODUCT
INFROMATION
DRUG
PRODUCT
QUALITY
RAW
MATERIALS-
ACTIVE &
INACTIVE
QC &
ANALYSIS
TRANSPORT
DISTRIBUTION
DISPENSING
& USE
MANUFACURING
PROCESSES
& PROCEDURES
STORAGE

11. QUALITY CONTROL

12. Quality Assurance 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

13. Quality Must Be Designed Into A Product
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

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

15. Analytical Control Laboratory
Heart of Quality Management in Pharmaceuticals
Academically trained and certified staff
Experienced supervision/management
Capable of performing complex analyses
Able to report honestly and in a timely manner
Equipment and instrumentation must be suitable for performing testing
Access to reliable power, water and other stable infrastructure

16. Quality Control & Analysis
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

17. Quality Assurance Throughout the Manufacturing Process
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

18. MANUFACTURING PROCESS AND PROCEDURES
Dispensing / Weighing
Mixing / Granulation / Preparation
Compression / Encapsulation / Filling
Equipment, Operational & Process Qualification
Validation & calibration
Documentation and record keeping
Yield Reconciliation

19. What is GMP? (WHO)
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

20. GMP Principles Must be built into manufacturing process
Prevents errors that cannot be eliminated through quality control of finished product
Ensures all units of a medicine are of the same quality (within specified parameters)
Poor medicines leads to loss of credibility for everyone: manufacturers, health care workers and governments
WHO Guidelines for GMP

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

22. WHO TECHNICAL GUIDE TO GMP
Validation
Action of proving (in accordance with principles of GMP) that any procedure, process, equipment, material, activity, or system actually leads to expected result.
Qualification
Action of proving that any premises, system, and items of equipment work correctly and actually lead to expected results

23. ASSOCIATED CONCEPTS Good Laboratory Practice (GLP)
Good Clinical Practice (GCP)
Clear language use
Effective record keeping
Design, installation, operational and process qualification (DQ, IQ, OQ and PQ)
Self-inspection and self-regulation
Good Distribution Practice (GDP)

24. KEY ELEMENTS OF GMP (WHO TECHNICAL GUIDE)
Sanitation and hygiene
Qualification and validation
Complaints
Product recalls
Contract Production and Analysis
Self-Inspection and Quality Audits

25. KEY ELEMENTS OF GMP (WHO TECHNICAL GUIDE)
Personnel
(Training, Hygiene)
Documentation Premises
(Equipment)
Materials
(Supplies, Ingredients)

26. Conclusions
Ensure appropriate infrastructure encompassing organizational structure, procedures, processes, and resources
Ensure systematic actions necessary to provide adequate confidence that product will meet quality standards and expectations.
Everyone’s responsibility (manufacturers, purchasers, distributors, consumers)

27. Thank you…..