by Dr. Yashashwini Reddy | Aug 8, 2025
5 Why Tool – Overview The 5 Why Tool is a simple but powerful problem-solving method used to identify the root cause of an issue by repeatedly asking “Why?” until the underlying reason is found. Typically, five iterations of “Why” are enough to reveal the true root...
by Dr. Yashashwini Reddy | Aug 8, 2025
Possible Causes of Out of Specification (OOS) Results OOS results occur when the test results fall outside the predefined acceptance criteria or specification limits. Causes can be grouped into three main categories: 1. Laboratory Errors Instrumental issues:...
by Dr. Yashashwini Reddy | Aug 8, 2025
Resolving API Impurity Issues in Drug Development 1. Understanding the Issue In drug development, impurities in the Active Pharmaceutical Ingredient (API) can arise from: Starting materials or intermediates (process-related impurities) By-products from synthesis steps...
by Dr. Yashashwini Reddy | Jun 25, 2025
✅ GVP Module IX – Signal Management 📘 Purpose GVP Module IX provides comprehensive guidance for Marketing Authorisation Holders (MAHs) and regulatory authorities on how to perform signal management, which is a core part of pharmacovigilance. The goal is to ensure...
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...
