Validation in Pharmaceutical Industry -Concepts, Approaches & Guidelines

Validation is a process of establishing documentary evidence demonstrating that a procedure, process, or activity carried out in production or testing maintains the desired level of compliance at all stages. In Pharma Industry it is very important apart from final testing and compliance of product with standard that the process adapted to produce itself must assure that process will consistently produce the expected results. Here the desired results are established in terms of specifications for outcome of the process. Qualification of systems and equipment is therefore a part of process of validation. It is a requirement of food and drug, pharmaceutical regulating agencies like FDA's good manufacturing practices guidelines. Contents of the book include Chapter 1: Principles and tools of statistics used in validation and quality control of drugs Chapter 2: Validation-concepts and options Chapter 3: Validation Master Plan (VMP) and other documents Chapter 4: Organizing for validation Chapter 5: Calibration and qualification Chapter 6: Qualification of premises and validation of HVAC systems Chapter 7: Validation of utilities Chapter 8: Cleaning validation Chapter 9: Process validation and revalidation Chapter 10: Validation of packaging operations Chapter 11: Validation of some special processes-aseptic processes, lyophilization Chapter 12: Process validation of medical devices Chapter 13: Analytical method validation Chapter 14: Computer system validation Shri. P.P. Sharma is B.Pharm (BITS, Pilani) and M.Pharm (Punjab University). He has been Rank Holder both at Graduate Level and Post Graduate Level and was awarded Gold Medal by Punjab University. After a short stint with Pharmaceutical Industry, he joined Drugs Control Dept. of Delhi Govt. where he worked in various capacities and retired as Dy. Drugs Controller and Licensing Authority. During his Professional career he had opportunities for training by Govt. of India and International Bodies like WHO and DANIDA. His approach to enforcement of law was ‘enforcement by education’ and this led him to write books. He has 06 books to his credit. He is faculty to various training programmes of Govt. of India and guest faculty to several pharmacy educational institutions