Pharmaceutical Master Validation Plan
eBook - PDF

Pharmaceutical Master Validation Plan

The Ultimate Guide to FDA, GMP, and GLP Compliance

  1. 208 pages
  2. English
  3. PDF
  4. Available on iOS & Android
eBook - PDF

Pharmaceutical Master Validation Plan

The Ultimate Guide to FDA, GMP, and GLP Compliance

Book details
Table of contents
Citations

About This Book

The Master Validation Plan provides a roadmap to management for on-time start-up of facility operations, and validation of existing facilities, in compliance with GMP requirements. The lack of a comprehensive Master Validation Plan and well-documented validation procedures is the main reason that new drug, medical device, medical equipment, and rel

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Yes, you can access Pharmaceutical Master Validation Plan by Syed Imtiaz Haider in PDF and/or ePUB format, as well as other popular books in Medicine & Pharmacology. We have over one million books available in our catalogue for you to explore.

Information

Publisher
CRC Press
Year
2001
ISBN
9781420025392
Edition
1
Topic
Medicine
Subtopic
Pharmacology

Table of contents

  1. Front Cover
  2. PREFACE
  3. ACKNOWLEDGMENTS
  4. ABOUT THE AUTHOR
  5. PROLOGUE
  6. ABOUT THE BOOK
  7. CONTENTS
  8. 1 INTRODUCTION
  9. 2 CONCEPT OFQUALIFICATION/VALIDATION
  10. 3 REVALIDATION
  11. 4 FACILITY DESCRIPTION
  12. 5 DESCRIPTION OF BUILDING
  13. 6 EQUIPMENT DESCRIPTION
  14. 7 HVAC DESCRIPTION
  15. 8 UTILITIES DESCRIPTIONS
  16. 9 VALIDATION PROGRAM OVERVIEW
  17. 10 CALIBRATION PROGRAM SUMMARY
  18. 11 PREVENTIVE MAINTENANCE PROGRAM SUMMARY
  19. 12 KEY STANDARD OPERATING PROCEDURES (SOPs)
  20. 13 VALIDATION OF BUILDING
  21. 14 VALIDATIONOF UTILITY SYSTEMS
  22. 15 PROCESS DESCRIPTION FOR DRY PRODUCTION FACILITY: BUILDING A
  23. 16 PROCESS DESCRIPTION FOR LIQUID AND SEMISOLID PRODUCTION FACILITY: BUILDING B
  24. 17 PROCESS DESCRIPTION FOR PARENTERALS PRODUCTION FACILITY: BUILDING C
  25. 18 QUALIFICATION OF PROCESS EQUIPMENT
  26. 19 VALIDATION OF SUPPORT PROCESSES
  27. 20 QUALITY ASSURANCE/CONTROL LABORATORY VALIDATION
  28. 21 cGMP PROCEDURES AND PROGRAMS
  29. 22 VALIDATION SCHEDULE
  30. 23 DRAWINGS FOR ABC PHARMACEUTICAL PLANT
  31. RECOMMENDED READING
  32. Back Cover