Quality Control Training Manual: Comprehensive Training Guide for API, Finished Pharmaceutical and Biotechnologies Laboratories, 1st Edition (e-Book) book cover

Quality Control Training Manual

Comprehensive Training Guide for API, Finished Pharmaceutical and Biotechnologies Laboratories, 1st Edition

By Syed Imtiaz Haider

CRC Press

484 pages

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Paperback: 9781138077522
pub: 2018-07-31
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Hardback: 9781439849941
pub: 2011-02-16
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eBook (VitalSource) : 9780429192234
pub: 2016-04-19
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Description

Written to help companies comply with GMP, GLP, and validation requirements imposed by the FDA and regulatory bodies worldwide, Quality Control Training Manual: Comprehensive Training Guide for API, Finished Pharmaceutical and Biotechnologies Laboratories presents cost-effective training courses that cover how to apply advances in the life sciences

Table of Contents

Preface. Analytical Methods, Techniques and Quality Measures for General Pharmaceutical Products. Analytical Methods and Techniques for Biological Products. Laboratory Training Manual. Assessment of Training. Training Assessment with Quiz and Answers. Training Log. Analytical Method Validation Master Plan. Analytical Methods Validation Protocol. SOP for Annual Re-Qualification of HPLC Units. SOP for Annual Re-Qualification of GC Units. ABC Pharmaceutical Company. Regulations. Index.

About the Author

Syed Imtiaz Haider, Ph.D. is Quality Affairs Director at Gulf Pharmaceutical Industries (GPI) in the United Arab Emirates.

Subject Categories

BISAC Subject Codes/Headings:
MED009000
MEDICAL / Biotechnology
MED071000
MEDICAL / Pharmacology