by Dr. Yashashwini Reddy | Aug 18, 2025
Cleaning Validation of Manufacturing Equipment Cleaning validation is a documented process that ensures manufacturing equipment in the pharmaceutical industry is consistently cleaned to predetermined limits, preventing contamination and cross-contamination between...
by Dr. Yashashwini Reddy | Aug 18, 2025
📘 Preparation of Master Formula Record (MFR) A Master Formula Record (MFR) is a controlled document that serves as a blueprint for manufacturing a pharmaceutical product. It ensures product quality, consistency, and compliance with regulatory requirements. 🔑 Key Steps...
by Dr. Yashashwini Reddy | Aug 12, 2025
Quality Management System (QMS) 1. Definition A Quality Management System (QMS) is a structured framework of policies, procedures, processes, and resources that ensures pharmaceutical products consistently meet quality, safety, efficacy, and regulatory requirements.It...
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...
