Basics of Pharmaceutical Manufacturing and Quality Operations

ISBN-13: 9781032432052 / Twarda / 2024 / 200 str.

Shahid Bader Usmani

Opis

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.

Spis treści

1. Good Manufacturing Practice (GMP), Good Lab Practice (GLP) & Good Documentation Practice (GDP). 2. Concept of Calibration. 3. Reference Standards & Reagents. 4. Chemical Tests. 5. Physical Testing of Raw Materials, Intermediate and Finished Products. 6. Data Integrity. 7. Process Validation. 7.1. Protocol Generation. 7.2. Sampling and Testing Plan. 7.3. Process Validation Report Writing. 8. Cleaning Validation. 9. Method Development and Method Validation. 10. Qualification and Its Segments. 10.1. User Requirement Specification. 10.2. Functional Specification. 11. Stability Studies, Stability Indicating &methods Degradates. 12. Technology Transfer. 13. Dispensing. 14. Production. 15. Packaging. 16. Role of Quality Assurance. 17. Role of Quality Control. 18. Logisctics – Cold Chain Supply. 19. GMP For Biologics and Similar Medicines. 20. QA/QC Release.

O autorze

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 nonsterile 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..