by Dr. Yashashwini Reddy | Sep 20, 2025
1. Purpose To describe the procedure for performing and documenting Operational Qualification (OQ) of equipment, instruments, and systems to ensure they operate according to defined specifications and intended performance. 2. Scope This procedure applies to all...
by Dr. Yashashwini Reddy | Jun 9, 2025
What is a Validation Master Plan (VMP)? A Validation Master Plan is a high-level document that outlines the overall strategy, scope, approach, and responsibilities for validation activities within a pharmaceutical facility. It serves as a roadmap to ensure all...
by Dr. Yashashwini Reddy | May 19, 2025
A Site Acceptance Test (SAT) is a critical phase in the commissioning process of equipment or systems. Conducted at the customer’s site after installation, the SAT verifies that the system operates according to specified requirements in its actual operating...
by Dr. Yashashwini Reddy | May 2, 2025
Structure of a URS Document for Pharmaceutical Equipment A well-structured URS should include the following key sections: 1. Title Page Document title (e.g., “User Requirement Specification for [Equipment Name]”) Document number and version Prepared by /...
by Dr. Yashashwini Reddy | May 2, 2025
Here’s a comprehensive and detailed explanation of the standard qualification process for a vial washing machine used in pharmaceutical manufacturing: Standard Qualification Process for a Vial Washing Machine Qualification is a critical aspect of pharmaceutical...
