by Dr. Yashashwini Reddy | Sep 6, 2025
Case Studies: Troubleshooting Purified Water System Failures A Purified Water (PW) System must consistently supply water that meets pharmacopeial standards (USP, EP, IP, JP) for use in manufacturing, cleaning, and testing. Failures in the system can lead to OOS...
by Dr. Yashashwini Reddy | Aug 29, 2025
1. Purpose To define the procedure for proper cleaning of the Dry Heat Sterilizer (DHS) to prevent contamination and ensure compliance with GMP requirements. 2. Scope This SOP is applicable to the cleaning of DHS used for depyrogenation/sterilization of vials,...
by Dr. Yashashwini Reddy | Aug 29, 2025
1.0 Purpose To describe the procedure for cleaning and maintaining the oven/incubator (55°C) to ensure it remains in a clean and contamination-free condition for reliable operation. 2.0 Scope This SOP applies to the cleaning of the oven/incubator maintained at 55°C...
by Dr. Yashashwini Reddy | Aug 18, 2025
📌 Temperature and Humidity Validation/Mapping in Storage Area Overview:Temperature and humidity mapping is a critical activity in pharmaceutical warehouses, cold rooms, and storage areas to ensure that medicinal products are stored under controlled conditions as per...
by Dr. Yashashwini Reddy | Aug 18, 2025
Cleaning Validation Procedure for Clean-in-Place (CIP) Systems 1. Objective To establish a validated cleaning procedure for Clean-in-Place (CIP) systems ensuring removal of product residues, cleaning agents, and microbial contaminants to acceptable levels. 2. Scope...
