quality assurance

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QUALITY ASSURANCE PRESENTATION BY: GUIDED BY: PROF. U. S. BAGUL MR. G. M. RASVE M. PHARM (1st SEM.) (PHARMACEUTICS) SINHGAD INSTITUTE OF PHARMCY,NARHE, PUNE-41 M.PHARM. (PHARMACEUTICS) 1

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12/27/2010 2 CONTENTS Quality assurance Quality control QC of raw material & finished products I.P.Q.C. Sources of variation Critical points Documentation Statistics References

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QUALITY ??? BSI: “The totality of features and characteristics of a product or service that bear on its ability to satisfy stated or implied needs” 12/27/2010 3

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ASSURANCE ??? “The act of giving confidence, the state of being certain or the act of making certain” 12/27/2010 4

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QUALITY ASSURANCE ??? According to WHO: “QA is a wide ranging concept covering all matters that individually or collectively influence the quality of a product” According to ISO 9000: “All those planned and systematic activities implemented to provide adequate confidence that an entity will fulfill requirements for quality” 5 12/27/2010

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CONCEPT OF QUALITY Characteristics of pharmaceutical product to be as quality product are: Identity Strength Safety Purity Efficacy 6 12/27/2010

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GOAL OF QA All activities related to satisfy quality standards for a product Continuous quality improvement Benchmarking can be used to generate ideas for quality improvements To ensure compliance with relevant statutory and safety requirements To achieve and maintain a level of quality which enhances the Company's or organisation’s reputation with customers To guarantee to all customers and to authorities : The total traceability of the products The suitability of the products to the customer requirements 7 12/27/2010

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components of q.a. The system of Q.A. should ensure that- Requirement of GMP,GLP etc. Operations in a written form and GMP requirements are adopted. Managerial responsibilities are clearly specified in job description. Made arrangements. All controls. The finished product is correctly processed, and checked. Certification. Quality audit. 8 12/27/2010

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functions of q.a. GMP Qualification and validation Complaints Product recalls Self-inspection and quality audits Documentation 9 12/27/2010

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Pharmacology/toxicology clinical trial Development Research Overall functions of q.a. QC GMP QA 10 12/27/2010

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QUALITY RELATIONSHIP 11 12/27/2010

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QUALITY CONTROL ??? According to WHO: “QC is a part of GMP concerned with sampling, specifications, testing, with the organization, documentation and release procedures which ensure that the necessary and relevant test are actually carried out and that materials are neither released for use, nor products released for sale or supply, until their quality has been satisfactory” According to ISO 9000: “The operational techniques and activities that are used to fulfil the requirements for quality” 12 12/27/2010

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13 12/27/2010

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q.C. OF RAW MATERIAL & FINISH PRODUCT Outline of various QC test for different properties of product 14 12/27/2010

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Purpose: To insure batch uniformity and integrity of drug product Procedures for I.P.Q.C. should describe: In process controls and their limits Tests and examinations to be conducted Sampling procedures of each batch I.P.Q.C.: For manufacturing operations For packaging operations I.P.Q.C. 15 12/27/2010

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DRUG PRODUCT QUALITY LABELLING RAW MATERIALS MANUFACURING PROCESSES & PROCEDURES STORAGE TRANSPORT DISTRIBUTION QC & ANALYSIS PERSONNEL PACKAGING SOURCES OF VARIATION 16 12/27/2010

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1) CRITICAL PROCEDURES Specifications Records SOP’s Site master file Validation master plan Self inspection Assembling & operation of equipments CRITICAL POINTS 17 12/27/2010

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2) CRITICAL STAGES IN FORMULATION 18

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DOCUMENTATION Definition: it is any written statement or proof Objectives Importance Preparation, issue & use of documentation Storage & retention Storage & retrieval 19 12/27/2010

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Different types of documents 20 12/27/2010

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STATISTICAL Q.C. It is “the monitoring of quality by application of statistical methods in all stages of production” These methods are based on the theory of probability. Normal frequency distribution Quality control charts: control charts by variables control charts by attributes 21 12/27/2010

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NORMAL FREQUENCY DISTRIBUTION Frequency Measured magnitude 22 12/27/2010

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Fig.: Frequency distribution with the same mean but different standard deviation 23 12/27/2010

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QUALITY CONTROL CHARTS Control charts by variables: Table: Process control record of automatic filling of parenteral solution in vials 24 12/27/2010

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Fig.: control chart for automatic filling of a parenteral solution in vials 25 12/27/2010

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Table: Process control record and control limits calculated (for ten batches of a parenteral product) Control charts by attributes: 26 12/27/2010

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Fig.: control chart (p chart) for percentage of defective units inspected for a parenteral product 27 12/27/2010

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REFERENCES: “Pharmaceutical Quality Assurance”, by M. A. Potdar, 2nd edition, Nirali Publication “The Theory & Practice Of Industrial Pharmacy”, by Leon lachman, H. A. Lieberman, J. L. Kanig, 3rd edition, Varghese Publishing House, Hind Rajasthan Building Dadar, Bombay-400 014, p.g. 804-855 “Quality Assurance In Higher Education: An Introduction”, by Dr. Sanjay Mishra, national assessment and accreditation council, Bangalore, India and commonwealth of learning, Vancouver, Canada, p.g. 11-13 28 12/27/2010

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THANK YOU !!! 29 12/27/2010