دانلود کتاب How to Validate a Pharmaceutical Process. Part of the Expertise in Pharmaceutical Process Technology Series

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Content:
Front-matter,Copyright,Dedication,Author Biography,Preface,Acknowledgment,About the Expertise in the Pharmaceutical Process Technology SeriesEntitled to full textSection I: Introduction to Process ValidationChapter 1 - Introduction to Process Validation (PV), Pages 3-13
Chapter 2 - A Brief Review of the Regulations*, Pages 15-31
Chapter 3 - The Validation Life Cycle and Change Control, Pages 33-42
Chapter 4 - Getting Started, Pages 45-58
Chapter 5 - Basic Equipment and Utility Qualification1, Pages 59-70
Chapter 6 - Computers and Automated Systems, Pages 71-86
Chapter 7 - Process Development*, Pages 89-102
Chapter 8 - The Process Validation Protocol—PPQ, Pages 103-112
Chapter 9 - Dealing With Deviations, Pages 113-118
Chapter 10 - Stage III—Collection and Evaluating Production Data, Pages 121-130
Chapter 11 - Cleaning and Facility Qualification, Pages 133-140
Terms and Definitions, Pages 141-151
Appendix A - 21 CFR 211, Pages 153-190
Appendix B - Example—Short Change Control Form, Pages 191-192
Appendix C - Additional ICH and FDA Guidelines, Pages 193-194
Index, Pages 195-199