by Dr. Yashashwini Reddy | Aug 18, 2025
📘 Preparation of Batch Packaging Record (BPR) A Batch Packaging Record (BPR) is a controlled document that provides a detailed account of the packaging process for a specific batch of a pharmaceutical product. It ensures traceability, compliance with GMP, and...
by Dr. Yashashwini Reddy | Aug 18, 2025
Cleaning Validation of Pharmaceutical Equipment Cleaning Validation is a documented process that provides a high degree of assurance that equipment used in the manufacturing of pharmaceutical products is consistently cleaned to predetermined and acceptable limits. It...
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
Criteria to Choose the Correct Swab for Cleaning Validation Cleaning validation in pharmaceuticals ensures that residues from previous products, cleaning agents, or contaminants are effectively removed from manufacturing equipment to prevent cross-contamination.Swab...
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,...
