by Dr. Yashashwini Reddy | May 8, 2025
STANDARD OPERATING PROCEDURE (SOP) 1.0 OBJECTIVE To establish a standard procedure for cleaning the capsule filling line to ensure product quality, prevent cross-contamination, and comply with regulatory requirements. 2.0 SCOPE This SOP...
by Dr. Yashashwini Reddy | May 2, 2025
When selecting detergents for cleaning pharmaceutical equipment, it is critical to ensure that the detergent is effective in removing contaminants while maintaining the integrity of the equipment and adhering to regulatory standards. The factors to consider when...
by Dr. Yashashwini Reddy | Nov 24, 2024
Understanding Dirty Hold Time in Pharmaceutical Equipment Cleaning Dirty Hold Time (DHT) refers to the duration during which pharmaceutical equipment remains uncleaned after completing a manufacturing process. This period begins when the production ends and ends...
by Dr. Yashashwini Reddy | Nov 22, 2024
What is a Validation Protocol? A Complete Guide for the Pharmaceutical Industry In the pharmaceutical industry, achieving and maintaining high standards of quality is non-negotiable. A validation protocol is one of the critical tools that ensure processes, equipment,...
by Dr. Yashashwini Reddy | Oct 21, 2024
Identifying the Worst Case in Cleaning Validation In cleaning validation, determining the worst-case scenario is essential to ensure that the cleaning procedures effectively remove the most challenging residues from manufacturing equipment. This scenario represents...
