by Dr. Yashashwini Reddy | Aug 18, 2025
FDA Requirements for Training in Pharmaceuticals The U.S. Food and Drug Administration (FDA), under 21 CFR Part 211 (cGMP for Finished Pharmaceuticals) and ICH Q10 Pharmaceutical Quality System, outlines clear expectations for employee training. 1. Training Program...
by Dr. Yashashwini Reddy | Aug 18, 2025
Importance of Validation in Pharmaceuticals Validation in pharmaceuticals is a critical quality assurance tool that ensures products are consistently manufactured to meet predetermined specifications and regulatory requirements. Its importance can be summarized as...
by Dr. Yashashwini Reddy | Aug 18, 2025
Requirements for Good Documentation Practice (GDP) Legibility All entries should be clear, readable, and permanent (no pencil or erasable ink). Accuracy Data should reflect the actual observation, measurement, or action without manipulation. Contemporaneous Recording...
by Dr. Yashashwini Reddy | Aug 12, 2025
How to Review GMP Documents Like a Pro 1. Understand the Purpose Identify what the document is for (e.g., SOP, batch record, protocol, report). Know the applicable GMP guidelines (US FDA, EMA, WHO, ICH). 2. Check for Compliance Ensure the document aligns with: Current...
by Dr. Yashashwini Reddy | Aug 10, 2025
QC Audit Checklist 1. General Documentation & Records SOPs for all QC activities (latest approved versions, controlled copies). Records of training, competency assessments, and analyst qualification. QC logbooks (instrument usage, calibration, maintenance). Change...
