by Dr. Yashashwini Reddy | Aug 9, 2025
Out of Specification (OOS) Investigation in Pharmaceuticals Definition OOS results are test results that fall outside the pre-established acceptance criteria defined in specifications, procedures, or regulatory filings.They can occur in raw materials, in-process...
by Dr. Yashashwini Reddy | Aug 9, 2025
4 Steps to Effective Change Control in Pharmaceuticals 1. Initiation & Documentation Identify the need for change (equipment, process, material, method, etc.). Document the proposed change in a Change Control Form with details like scope, reason, impact area, and...
by Dr. Yashashwini Reddy | Jun 9, 2025
Definition: Self-inspection is a critical component of the pharmaceutical Quality Management System (QMS). It refers to the internal evaluation of all aspects of Good Manufacturing Practices (GMP) within a pharmaceutical facility. The goal is to ensure compliance with...
by Dr. Yashashwini Reddy | May 19, 2025
A Quality Management System (QMS) is a structured framework comprising processes, procedures, and responsibilities aimed at consistently delivering products or services that meet customer expectations and regulatory requirements. It serves as the backbone of an...
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...
