Pharmaceutical Manufacturing Deviation and Failure Investigations

Dr. Ajay Babu Pazhayattil, President, cGMPWorld, Toronto, CanadaDr. Ajay Pazhayattil is an accomplished management consultant and industrial pharmacist with extensive experience spanning solid oral, sterile, and API manufacturing sectors. He is the founder of cGMP World and a founding partner of ITAAN Pharma, an injectable manufacturer. Dr. Pazhayattil has held key leadership positions with prominent North American brands, generic manufacturers, and CDMOs. His roles include Vice President of Scientific and Regulatory Affairs at Capcium, Quality Director at Eurofins, and Associate Director at Apotex. He plays a pivotal role in guiding organizations through remediation efforts related to US FDA 483 observations and warning letters. He has been a lead author and contributor to industry guidance documents published by renowned industry organizations such as AAPS, PDA, ISPE, and RAPS. Sanjay Sharma, Senior Vice President and Head, Manufacturing Science and Technology, Zydus Group, Ahmedabad, IndiaSanjay is a seasoned pharmaceutical industry professional with over 25 years of experience in the development, launch, and maintenance of drug supply. He possesses a results-driven approach and a deep understanding of pharmaceutical manufacturing science, which has enabled him to contribute to the success of some of the largest organizations in the industry. Sanjay has held various leadership positions in Indian and multinational pharmaceutical companies such as Cipla, Dr. Reddy's Laboratories, Sandoz, Watson, Torrent, and Lupin. He is widely recognized for his expertise in streamlining technical operations and driving innovation to enhance product quality and regulatory compliance.

• Chapter 1: Initial Actions and Information Gathering.- Chapter 2: Root Cause Analysis (RCA) Methods.- Chapter 3: Analytical Tools for Investigation and Generation of Supporting Evidence.- Chapter 4: Management of Deviation and Failure Investigation.- Chapter 5: Post-RCA Impact Assessment, CAPA, and Effectiveness Checks.- Chapter 6: Case Study: Dissolution OOT Observed for an Extended-Release Tablet Formulation.- Chapter 7: Case Study: OOS Uniformity of Dosage Units (Stratified Samples) for a Capsule Formulation.- Appendix I: Non-Conformance/Deviation Investigation.- Appendix II: OOS Failure Investigation.- Appendix III: Review of CDMO Investigation Report.