by Dr. Yashashwini Reddy | May 7, 2025
Standard Operating Procedure (SOP) 1. Objective To establish standardized procedures for reprocessing and reworking pharmaceutical products to ensure that all batches meet predefined specifications and maintain product quality. 2. Scope...
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 | Oct 9, 2024
“Top QMS Interview Questions Every Pharmaceutical Professional Should Know” 1. What is Change Control in QMS? Answer: Change control is a systematic approach used in the pharmaceutical industry to manage any modifications to processes, documentation, or...
by Dr. Yashashwini Reddy | May 28, 2024
Departure from an approved procedure, instruction, or documented procedure is called deviation. A deviation should be properly documented and handled. A deviation can occur during the manufacturing, testing, storage, or distribution of pharmaceuticals. Deviations most...
