by Dr. Yashashwini Reddy | Jun 9, 2025
Validation of Compressed Air frame 1. Introduction Importance of compressed air in pharmaceutical manufacturing. Regulatory expectations (e.g., EU GMP Annex 1, ISO 8573, WHO guidelines). Role of compressed air in cleanroom environments, product...
by Dr. Yashashwini Reddy | May 7, 2025
Standard Operating Procedure (SOP) Here’s a comprehensive Standard Operating Procedure (SOP) for Garment Change and Entry/Exit Through First and Primary Change Rooms in a pharmaceutical manufacturing facility. This procedure ensures...
by Dr. Yashashwini Reddy | Nov 28, 2024
Out of Specifications (OOS) in Pharmaceuticals Out of Specification (OOS) results occur when the test results of a pharmaceutical product fall outside the predefined acceptance criteria specified in regulatory guidelines or quality standards. These deviations are...
