by Dr. Yashashwini Reddy | Jun 9, 2025
Cleaning Validation Procedure for Clean-in-Place (CIP) Systems Purpose:To establish and document a systematic approach ensuring that the Clean-in-Place (CIP) system effectively cleans equipment and piping without manual disassembly, preventing cross-contamination and...
by Dr. Yashashwini Reddy | Jun 9, 2025
Recovery Factor Determination in Cleaning Validation What is Recovery Factor?Recovery Factor (RF) is a measure of how effectively an analytical method can extract and detect a known quantity of residue from a surface or sampling medium (e.g., swabs, rinse solutions)...
by Dr. Yashashwini Reddy | Jun 9, 2025
Three Consecutive Batches for Validation in Pharmaceuticals Definition: In pharmaceutical manufacturing, validation is the documented evidence that a process consistently produces a product meeting its predetermined quality specifications. One of the critical...
by Dr. Yashashwini Reddy | May 15, 2025
Standard Operating Procedure (SOP) Here’s a comprehensive Standard Operating Procedure (SOP) for the Cleaning and Maintenance of a Fogger, typically used in pharmaceutical manufacturing for disinfection purposes. 1. Purpose...
by Dr. Yashashwini Reddy | May 15, 2025
Standard Operating Procedure (SOP) Here is a detailed Standard Operating Procedure (SOP) for Line Clearance in the Manufacturing Area, which is critical for preventing cross-contamination, ensuring product integrity, and complying with cGMP...
