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Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry
ISBN-13:
9783319501864
Veröffentl:
2017
Seiten:
379
Autor:
Richard K. Burdick
Serie:
Statistics for Biology and Health
eBook Typ:
PDF
eBook Format:
EPUB
Kopierschutz:
1 - PDF Watermark
Sprache:
Englisch
Beschreibung:
This book examines statistical techniques that are critically important to Chemistry, Manufacturing, and Control (CMC) activities. Statistical methods are presented with a focus on applications unique to the CMC in the pharmaceutical industry.
Chapter 1. Introduction.- Chapter 2. Statistical Methods for CMC Applications.- Chapter 3. Process Design: Stage 1 of the FDA Process Validation Guidance.- Chapter 4. Process Qualification: Stage 2 of the FDA Process Validation Guidance.- Chapter 5. GMP Monitoring and Continuous Process Verification: Stage 3 of the FDA Process Validation Guidance.- Chapter 6. Analytical Procedures.- Chapter 7. Specifications.- Chapter 8. Stability.- Chapter 9. Analytical Comparability and Similarity.
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