Quality Operations Procedures for Pharmaceutical, API, and Biotechnology
|Rating||:||4.99 (822 Votes)|
|Number of Pages||:||584 Pages|
He has worked in US FDA- and Health Canadaâ€“approved facilities in managerial positions under the quality operations umbrella. Dr. Haider is currently involved in several major biotechnology-based tasks, including cell-line qualification, process validation, biological analysis, method validation, biosimilars com
"Good starting point for SOPs" according to Matt B. Good starting point for SOPs, but I don't think it's very in line with current industry practice in the U.S. Having the CD is very nice for traveling consultants.
About the AuthorSyed Imtiaz Haider, Ph.D. is a quality assurance and environmental specialist with over 20 years of experience in aseptic and nonaseptic pharmaceutical processes, equipment validation, and in-process control and auditing. Dr. He is the author and coauthor of more than 20 research publications in international refereed journals dealing with products of pharmaceutical interest, their isolation, and structure development.Erfan Syed Asif, Ph.D. has over 17 years of experience in various areas of quality operations in pharmaceutical industries in Pakistan, the United States, Canada, and the UAE. He has extensive experience in overseeing qualification projects for manufacturing equipments, utilities, systems, sterilization techniques, aseptic processes simulation test, and the sterile and nonsterile products manufacturing process.. Haider is cur
To stay in compliance with regulations, pharmaceutical, medical, and biotech companies must create qualtiy SOPs that build in the regulatory requirements into actions and describe personal flow, internal flow, flow of information, and processing steps. The book ensures minimization of the number of documents, helping to reduce the nightmare-like aura that surrounds an FDA audit. No other resource deals exclusively with the key elements of quality control and quality assurance procedures for pharmaceutical operation