part I-Lecture 1.pdf

Quality Control & Pharmaceutical Analysis 1 2 3 4 5 6 7  Lecture 1 Quality Control, Quality Assurance And Good manufacturing practices 8  Introduction to Quality Control Overview: Quality control means different thi...

Quality Control & Pharmaceutical Analysis 1 2 3 4 5 6 7  Lecture 1 Quality Control, Quality Assurance And Good manufacturing practices 8  Introduction to Quality Control Overview: Quality control means different things to different people according to the field of interest. Quality control is the responsibility of everyone in an project. Quality control in medicine is an old concept as there has been a need to control the quality of its performance. Since the 20th century other factors have come into consideration. Modern synthetic drugs may be toxic by itself and/or contain toxic impurities by virtue of their manufacturing methods, reagents and intermediates. 9 What is meant by quality? Quality is the grade of excellence possessed by an item Quality is the ability to satisfy stated needs. Quality is a product or service free of deficiencies. Quality has to be related to specific function or object Quality is an intrinsic characters of the finished products Quality attributes in operations management 10 of Improvement 11  The characteristics of the drug which determine its quality The suitability of drugs for their intended use may be determined by: Their efficacy weighed against safety according to the label claim Their conformity to specifications regarding identity, purity, potency, uniformity, bioavailability, and stability. Identity: The correct active ingredient (A. I.) is present Purity: The drug is not contaminated with harmful materials Potency: The correct amount of A.I. is present (usually 100 ± 10% of the labeled amount) Uniformity: consistency, color shape, and size of dosage form do not vary any when and any how Bioavailability: speed and completeness of entry to the blood stream Stability: The activity of the drug is assured until the expiry date 12  Quality Control and Quality Assurance Quality assurance means; (Prevention of defects) All those planned and systematic actions necessary to: provide adequate confidence that a product will satisfy given requirements for quality ensure that the QC activities are being properly done Quality control means; (Detection of defects) All the operational techniques and activities that are used to perform the requirements for quality provide a quality product. 13 14  Good Manufacturing Practices (GMP) The minimum requirements that the industry must meet when manufacturing, processing, packing, or holding drugs for human and veterinary use. is part of is part of Quality Control Quality GMP Assurance Concerned with sampling, specifications, testing, Concerned with organization, documentation production & quality control & release Takes place within a Quality Management system 15  Good Manufacturing Practices (GMPs) is part of is part of Quality Quality Control GMP Assurance Concerned with sampling, specifications, testing, organization, documentation & release Takes place within a Quality Management system 16 Objectives of quality control To assure that the drug products in the markets fulfill the requirements in terms of safety, efficacy, and quality. To ensure the stability of the active ingredients in the finished products. To assure that the drug products contain the labeled mount of the active constituent (s) within the accepted limits 17 18 WHO Certification Scheme WHO has produced this scheme for the QC of pharmaceutical products moving in International trade especially for the importing countries. It is an international voluntary agreement, created to enable countries with limited drug regulatory capacity to obtain partial assurance from exporting countries concerning the safety, quality and efficacy of the products they plan to import. http://www.who.int/medicines/areas/quality_safety/regulation_legislation/c ertification/en/ On this website you can find information about: Competent authorities participating in this certification scheme. Model certificate of a pharmaceutical product. Guidelines on the completion of this certification scheme. 19 Quality Policy It is the overall quality intentions and directions of an organization with respect to quality as formally expressed by the top management. Quality Systems The ISO, EN and BSI standards define a quality system as; the organizational structure, responsibilities, procedures, processes and resources for implementing quality management. Briefly the quality system is a combination of quality management, quality control and quality assurance. 20