eBook - PDF
Pharmaceutical Master Validation Plan
The Ultimate Guide to FDA, GMP, and GLP Compliance
- 208 pages
- English
- PDF
- Available on iOS & Android
eBook - PDF
Pharmaceutical Master Validation Plan
The Ultimate Guide to FDA, GMP, and GLP Compliance
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
Table of contents
- Front Cover
- PREFACE
- ACKNOWLEDGMENTS
- ABOUT THE AUTHOR
- PROLOGUE
- ABOUT THE BOOK
- CONTENTS
- 1 INTRODUCTION
- 2 CONCEPT OFQUALIFICATION/VALIDATION
- 3 REVALIDATION
- 4 FACILITY DESCRIPTION
- 5 DESCRIPTION OF BUILDING
- 6 EQUIPMENT DESCRIPTION
- 7 HVAC DESCRIPTION
- 8 UTILITIES DESCRIPTIONS
- 9 VALIDATION PROGRAM OVERVIEW
- 10 CALIBRATION PROGRAM SUMMARY
- 11 PREVENTIVE MAINTENANCE PROGRAM SUMMARY
- 12 KEY STANDARD OPERATING PROCEDURES (SOPs)
- 13 VALIDATION OF BUILDING
- 14 VALIDATIONOF UTILITY SYSTEMS
- 15 PROCESS DESCRIPTION FOR DRY PRODUCTION FACILITY: BUILDING A
- 16 PROCESS DESCRIPTION FOR LIQUID AND SEMISOLID PRODUCTION FACILITY: BUILDING B
- 17 PROCESS DESCRIPTION FOR PARENTERALS PRODUCTION FACILITY: BUILDING C
- 18 QUALIFICATION OF PROCESS EQUIPMENT
- 19 VALIDATION OF SUPPORT PROCESSES
- 20 QUALITY ASSURANCE/CONTROL LABORATORY VALIDATION
- 21 cGMP PROCEDURES AND PROGRAMS
- 22 VALIDATION SCHEDULE
- 23 DRAWINGS FOR ABC PHARMACEUTICAL PLANT
- RECOMMENDED READING
- Back Cover