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...
by Dr. Yashashwini Reddy | Jul 1, 2024
A product needs to be tested and proven for its quality and compliance requirements before it reaches the factory to the consumer. With the increasing complexity of the equipment being manufactured as per consumer demand, there is a chance for countless errors. So,...
