by Dr. Yashashwini Reddy | Sep 20, 2025
1. Purpose To establish a procedure for regular inspection of utilities (e.g., purified water, compressed air, HVAC system, steam, and gas supply) to ensure compliance with GMP requirements and operational efficiency. 2. Scope This procedure applies to all utility...
by Dr. Yashashwini Reddy | Aug 18, 2025
✅ 30 Common Ways to Avoid the Most Frequent GMP Errors Follow approved SOPs strictly. Ensure proper documentation – never backdate or predate entries. Maintain good record-keeping practices (ALCOA+ principles). Always perform line clearance before starting new...
by Dr. Yashashwini Reddy | Aug 9, 2025
GMP Requirements in Pharmaceuticals Good Manufacturing Practice (GMP) is a regulatory framework ensuring that pharmaceutical products are consistently produced and controlled according to quality standards, minimizing risks to patients. 1. Quality Management System...
by Dr. Yashashwini Reddy | May 2, 2025
Common Sources of Contamination in Pharmaceutical Manufacturing Contamination in pharmaceutical production can lead to serious consequences, including compromised product quality, patient safety risks, regulatory violations, and financial losses. Contamination can be...
by Dr. Yashashwini Reddy | Apr 25, 2025
Standard Operating Procedure (SOP) Here’s a clear and structured Standard Operating Procedure (SOP) for Garment Change and Entry/Exit through the First and Primary Change Room, typically used in controlled environments like...
