by Dr. Yashashwini Reddy | Oct 9, 2025
In pharmaceuticals, specifications are a set of standards, tests, analytical procedures, and acceptance criteria that define the quality requirements for materials and products. They ensure that every product consistently meets its intended safety, efficacy, and...
by Dr. Yashashwini Reddy | Sep 13, 2025
Vendor Audit Checklist 1. General Information Vendor profile and organization structure available. Valid licenses, registrations, and certifications (GMP, ISO, GDP). Regulatory inspection history (FDA, EMA, WHO, local authorities). Change notification procedure in...
by Dr. Yashashwini Reddy | Sep 11, 2025
📌 Contamination Issues in Pharmaceutical Production and Their Prevention Definition:Contamination in pharmaceuticals refers to the undesired introduction of chemical, microbial, or physical material into drug products during manufacturing, packaging, storage, or...
by Dr. Yashashwini Reddy | Sep 11, 2025
📌 Deviation Control in Pharmaceuticals Definition:Deviation control in pharmaceuticals refers to the systematic process of identifying, documenting, investigating, and resolving any departure from approved processes, procedures, or specifications in a GMP-regulated...
by Dr. Yashashwini Reddy | Sep 10, 2025
👥 Checklist for Audit in HR / Admin (Pharmaceuticals) 1. Organization & Policies ✅ Organization chart updated and approved. ✅ HR policies documented (recruitment, promotion, disciplinary action). ✅ Job descriptions (JDs) defined, approved, and role-specific. ✅...
