What Went Wrong? Pharma Tech Case Studies: Pharma Regulatory Investigations

The objective of What Went Wrong? Pharma Tech Case Studies is to provide multidisciplinary approaches/guidelines for problem-solving capability. These case studies are based on the actual situation faced by the author in India and overseas and successfully resolved with the back-up of science and technology convincing international regulators/complainants leading to the closing of complaints.

The book provides guidelines covering regulatory requirements for documentation. How do you document (format) any complaint? How to investigate a case study, using knowledge of science and technology and method of investigation? How to reproduce the complaint in-house, where ever required? It answers these various questions. The conclusion is with corrective and preventive actions required, submission of the investigation report and assignable reason to the regulatory agency/complainant, getting a response from the complainant and once satisfied, requesting them to close the complaint.

Can we integrate regulatory science with other subjects of pharmaceutical sciences to learn 'What Went Wrong? In Pharma Tech Case Study'.

Important regulatory references are provided at the end.