by Dr. Yashashwini Reddy | Aug 27, 2025
Validation of Clean Room Pass Boxes 1. Introduction A pass box is an enclosed space with doors on both sides, installed between two areas of different cleanliness grades.It allows the transfer of materials with minimum air turbulence and controlled contamination...
by Dr. Yashashwini Reddy | Aug 18, 2025
How to Write a Validation Master Plan (VMP) A Validation Master Plan (VMP) is a high-level document that outlines a company’s overall philosophy, intentions, and approach for establishing performance qualification, validation, and compliance of its facilities,...
by Dr. Yashashwini Reddy | Aug 18, 2025
Validation of Compressed Air in Pharmaceuticals Compressed air is widely used in pharmaceutical manufacturing for processes like cleaning, drying, aeration, packaging, and equipment operation. Since compressed air may directly or indirectly come in contact with...
by Dr. Yashashwini Reddy | Aug 12, 2025
Concept of Revalidation in Pharmaceuticals 1. Definition Revalidation is the process of repeating validation (process, equipment, cleaning, or analytical method) to ensure that the system or process remains in a state of control throughout its lifecycle.It confirms...
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,...
