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Quality in the Manufacture of Medicines and other Healthcare Products

1st Edition

Publication Date   January 2000
Publisher   Pharmaceutical Press
Product Type   Book
Pages   528
ISBN Number   9780853694311
Product Code   PHP074
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Price £75.00

approximately: $140 | €95

Summary


This new reference source is essential reading for anyone with a responsibility for ensuring the quality of manufactured medicines and other healthcare products.

With the large scale industrial manufacture of medicines has come the potential for serious and widespread hazards. This has dictated the need for a rigorous and highly organised approach to the means of ensuring the quality of manufactured medicines.

As well as giving practical guidance on quality procedures, this book explains the fundamental principles of quality which should underpin the manufacture of medicines and other healthcare products.

This book will be invaluable to all those working in industrial or hospital manufacturing and to those students interested in a career in the pharmaceutical industry.

Content


  • Part One Principles
    • 1. Applications and Definitions
    • 2. The Concept of Quality
    • 3. The Regulatory Factor: Background
    • 4. QC, QA and GMP: Their Nature and Inter-relationships
    • 5. The Essentials of GMP: UK/EC and USA GMPs Compared
    • 6. Quality Assurance Beyond GMP; the Wider Aspects and the Cost of Quality
    • 7. The Quality Movement, 'quality Gurus', TQM and ISO 9000
  • Part Two Premises and Equipment
    • 8. Premises and Contamination Control
    • 9. Premises: Location, Design, Structure, Layout, Services and Cleaning
    • 10. Equipment
  • Part Three Personnel
    • 11. Personnel Management
    • 12. Training
    • 13. Personnel: Hygiene and Health
  • Part Four Documentation
    • 14. Documentation: General
    • 15. Documentation in Action
  • Part Five Quality Control
    • 16. Quality Control and Good Control Laboratory Practice (GCLP)
    • 17. Analytical Validation
    • 18. Laboratory Documentation and Records
  • Part Six Sterile and Other Products
    • 19. Sterile Products: Basic Concepts and Principles
    • 20. Assurance of Quality in the Manufacture of Sterile Products
    • 21. Non-sterile Manufacture and Packaging
  • Part Seven Validation
    • 22. Validation: Concepts, Principles and Terminology
    • 23. Validation: Applications
  • Part Eight Self-inspection/quality Audit and Other Techniques
    • 24. Self-inspection and Quality Audit
    • 25. SPC, HACCP and Other Techniques