Quality

The Pharmaceutical Engineering Series is a comprehensive reference for the pharmaceutical professional covering all aspects from quality, documentation and validation through manufacturing processes to facility design and management. In 'Quality', Dr Kate McCormick provides the reader with comprehensive coverage of this vital subject, including the quality life cycle, management and cost of quality, GMP, auditing and inspections. This book with the others in the series will become a unique source of reference and educational material for the readership. Case studies and examples make the book of direct practical relevance to the professional in the pharmaceutical industry Find the answers you are looking for quickly and easily with clear indexing and referencing Reference to international standards and practice mean this book will be useful wherever you are working

Includes bibliographical references (p. [260]-263) and index

11.3 Mutual recognition of inspections.

Front Cover; Quality; Copyright Page; Contents; Acknowledgements; Abbreviations; Chapter 1. Quality life cycle; 1.1 Introduction; 1.2 Research and development; 1.3 Good laboratory practice (GLP); 1.4 Good clinical practice (GCP); 1.5 Drug registration in the European Union; 1.6 Drug registration in the USA; 1.7 Unlicensed medicines; 1.8 Good manufacturing practice (GMP); 1.9 Good distribution practice (GDP); Chapter 2. Quality assurance and control; 2.1 Introduction; 2.2 Relationship between quality management, QA, GMP and QC; 2.3 Definition of quality management.

2.4 Definition of quality assurance2.5 Definition of quality control; 2.6 Responsibilities of QA; 2.7 Responsibilities of QC; Chapter 3. Quality systems; 3.1 Introduction; 3.2 ISO 9000 series; 3.3 ISO 14000 series; 3.4 Use of the quality systems approach within the pharmaceutical industry; 3.5 Case study; Chapter 4. Good manufacturing practice; 4.1 Introduction; 4.2 Definition of GMP; 4.3 Different versions of GMP; 4.4 Comparison of different GMP guidelines; 4.5 Responsibilities under GMP; 4.6 Rules versus guidelines; 4.7 Application of GMP; 4.8 Case studies; 4.9 Summary.

Chapter 5. Good distribution practice5.1 Introd…