by Naveen kumar | Nov 29, 2024
Advanced Questions and Answers on MS&T in Injectable Plants – Part 2 1. Troubleshooting and Continuous Improvement Question: What approach do you follow to troubleshoot a batch failure? Answer: Conduct a root cause analysis using tools like fishbone diagrams or 5...
by Naveen kumar | Nov 28, 2024
Out of Specifications (OOS) in Pharmaceuticals Out of Specification (OOS) results occur when the test results of a pharmaceutical product fall outside the predefined acceptance criteria specified in regulatory guidelines or quality standards. These deviations are...
by Naveen kumar | Nov 28, 2024
Why Data Integrity Matters in Pharmaceuticals: Insights from Patients and Regulators In pharmaceuticals, “data integrity” ensures data remains accurate, consistent, and reliable throughout its lifecycle. It forms the backbone of quality assurance in...
by Naveen kumar | Nov 27, 2024
Interview Questions and Answers for Drug Substance (3.2.S) in CTD – Regulatory Affairs (Freshers) 1. What is the role of 3.2.S in the CTD (Common Technical Document)? Answer: The 3.2.S section of the CTD is dedicated to the “Drug Substance,” which...
by Naveen kumar | Nov 26, 2024
Interview Questions on Common Technical Document (CTD) for Regulatory Affairs Freshers 1. What is the Common Technical Document (CTD)? Answer: CTD is a standardized format for submitting regulatory documents for drug approvals. It simplifies the submission process...
