by Dr. Yashashwini Reddy | Sep 1, 2025
🧼 Cleaning Validation of CIP Systems in Pharmaceuticals 🔹 What is CIP? Clean-in-Place (CIP) is an automated method for cleaning process equipment (bioreactors, fermenters, tanks, piping, filling lines) without disassembly. Ensures removal of residues (API, excipients,...
by Dr. Yashashwini Reddy | Sep 1, 2025
📌 Effective Deviation Management in Pharmaceutical Manufacturing 🔹 What is a Deviation? A Deviation is any departure from approved processes, procedures, specifications, or GMP requirements that may impact product quality, safety, data integrity, or regulatory...
by Dr. Yashashwini Reddy | Aug 28, 2025
1.0 Purpose To describe the standard procedure for the safe and effective operation of the Fogster-ULV (Ultra-Low Volume) Fogger Machine for disinfection of classified and controlled areas in the facility. 2.0 Scope This SOP applies to all trained personnel...
by Dr. Yashashwini Reddy | Aug 27, 2025
Purified Water Storage and Distribution System in Pharmaceuticals Purified water is a critical utility in pharmaceutical manufacturing, widely used in formulations, cleaning, rinsing, and as a raw material. A robust storage and distribution system ensures that water...
by Dr. Yashashwini Reddy | Aug 18, 2025
✅ Tips to Develop Equipment Cleaning Procedure Risk Assessment First Identify the potential for cross-contamination, product carryover, and microbial risks. Classify equipment as product-contact or non-product-contact. Define Cleaning Scope Clearly specify which...
