by Dr. Yashashwini Reddy | May 5, 2025
Tips for Preventing and Troubleshooting Manufacturing Deviations Manufacturing deviations are any unintended differences or variations from the planned production process or product specifications. These can result in quality issues, production delays, and increased...
by Dr. Yashashwini Reddy | Apr 29, 2025
Analysis of Out of Specification (OOS) Occurrences in Pharmaceutical Products In the pharmaceutical industry, the term Out of Specification (OOS) refers to situations where the results of tests or measurements fall outside the predefined limits or specifications set...
by Dr. Yashashwini Reddy | Apr 28, 2025
Introduction In the pharmaceutical industry, ensuring product quality, patient safety, and regulatory compliance is critical. When deviations, non-conformances, or process failures occur, it is essential to not only correct the immediate problem but also to identify...
by Dr. Yashashwini Reddy | Apr 26, 2025
Standard Operating Procedure (SOP) 1. Purpose To outline the procedure for investigating failures in processes, systems, products, or equipment to determine root causes, implement corrective actions, and prevent recurrence. 2. Scope This SOP...
by Dr. Yashashwini Reddy | Apr 20, 2025
Standard Operating Procedure (SOP) 1. Purpose: To define the procedure for managing and handling non-conforming products (NCP) in order to identify, segregate, and address quality issues, ensuring that only conforming products are released for use,...
