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,...
by Dr. Yashashwini Reddy | Apr 11, 2025
Isn’t it amazing to be alive right now? We have answers to almost any question at our fingertips, thanks to the tiny device we carry in our hands. However, even with all these incredible resources, things don’t always go as planned, and we still face...
by Dr. Yashashwini Reddy | 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...
