Description

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This book describes "good practice" GxP activities that are directly related to quality, safety and efficacy in the pharmaceutical industry. The material provides guidance on how to evaluate, audit, qualify and approve a pharmaceutical product to enhance the GMP within the industry.

About the Author

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Erfan Syed Asif earned his PhD in organic chemistry and has expertise in various areas of quality operations with over 28 years of experience in pharmaceutical industries in Pakistan, UAE, Kingdom of Saudi Arabia, United States, and Canada. He has worked in U.S. FDA- and Health Canada-approved facilities in various Leading roles. He has extensive experience in overseeing qualification projects for manufacturing equipment, utilities, systems, sterilization techniques, aseptic processes simulation, API site audits and sterile and non-sterile products manufacturing processes, and decommissioning of equipment.Usmani Shahid Bader obtained his Ph.D. in organic chemistry and has expertise in various areas of quality operations with over 25 years of experience in pharmaceutical industries in Pakistan and Canada. He has worked in a leading role in U.S. FDA- and Health Canada-approved facilities. He has extensive experience in overseeing quality projects.