QUALITY ASSURANCE AND QUALITY CONTROL IN GENERICS

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

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.

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

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.

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

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.

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

QUALITY ASSURANCE: ESSENTIAL AT ALL STAGES

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

QUALITY CONTROL

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

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

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

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

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

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

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

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

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

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

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

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)

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

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

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)

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