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OverviewFull Product DetailsAuthor: Erfan Syed Asif , Shahid Bader UsmaniPublisher: Taylor & Francis Ltd Imprint: CRC Press Weight: 1.430kg ISBN: 9781032432052ISBN 10: 1032432055 Pages: 254 Publication Date: 14 March 2024 Audience: College/higher education , Professional and scholarly , Tertiary & Higher Education , Professional & Vocational Format: Hardback Publisher's Status: Active Availability: In Print This item will be ordered in for you from one of our suppliers. Upon receipt, we will promptly dispatch it out to you. For in store availability, please contact us. Table of ContentsPreface Chapter 1 Good Manufacturing Practice (GMP), Good Lab Practice (GLP) and Good Documentation Practice (GDP) Chapter 2 Concept of Calibration Chapter 3 Reference Standards and Reagents Chapter 4 Chemical Tests Chapter 5 Physical Testing of Raw Materials, Intermediate, and Finished Products Chapter 6 Data Integrity Chapter 7 Process Validation Chapter 7.1 Protocol Generation Chapter 7.2 Sampling and Testing Plan Chapter 7.3 Process Validation Report Writing Chapter 8 Cleaning Validation Chapter 9 Method Development and Method Validation Chapter 10 Qualification and Its Segments Chapter 10.1 User Requirement Specification Chapter 10.2 Functional Specification Chapter 11 Stability Studies, Stability Indicating,and Methods Degradates Chapter 12 Technology Transfer Chapter 13 Dispensing Chapter 14 Production Chapter 15 Packaging Chapter 16 Role of Quality Assurance Chapter 17 Role of Quality Control Chapter 18 Logistics – Cold Chain Supply Chapter 19 GMP for Biologics and Similar Medicines Chapter 20 QA/QC Release IndexReviewsAuthor InformationErfan 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. Tab Content 6Author Website:Countries AvailableAll regions |