by Dr. Yashashwini Reddy | Aug 18, 2025
Site Acceptance Test (SAT) The Site Acceptance Test (SAT) is the final phase of equipment/system qualification, conducted at the customer’s site after installation and commissioning. It verifies that the system, machine, or equipment functions correctly in the actual...
by Dr. Yashashwini Reddy | Aug 12, 2025
How to Write a Validation Protocol A Validation Protocol is a formal, approved document describing how validation will be performed, including the methodology, acceptance criteria, responsibilities, and documentation requirements.It applies to Process Validation,...
by Dr. Yashashwini Reddy | Aug 8, 2025
User Requirement Specification (URS) of Equipment 1. Definition The URS is a document prepared by the end user that clearly defines the functional, operational, and regulatory requirements an equipment must meet before procurement or qualification.It serves as a...
by Dr. Yashashwini Reddy | May 2, 2025
Revalidation plays a critical role in maintaining product quality and ensuring regulatory compliance in pharmaceutical manufacturing. It is an essential component of Good Manufacturing Practices (GMP) and a requirement by regulatory authorities like the FDA, EMA, and...
by Dr. Yashashwini Reddy | Apr 26, 2025
Standard Operating Procedure (SOP) 1. Purpose To define the procedure for the qualification of equipment used in regulated environments (e.g., manufacturing, laboratory, or healthcare) to ensure that it operates as intended, performs...
