by Dr. Yashashwini Reddy | Jun 9, 2025
Importance of Validation in Pharmaceuticals Validation in the pharmaceutical industry is a documented process that proves that a system, equipment, method, or process consistently produces a result meeting predetermined quality standards. It is a fundamental part of...
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
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 19, 2025
A Systematic Investigation of Out-of-Specification (OOS) Results in Analytical Testing is a structured approach to identify, evaluate, and resolve instances where test results fall outside predefined specifications. This process is vital in pharmaceutical quality...
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...
