by Dr. Yashashwini Reddy | Aug 18, 2025
📘 Preparation of Master Formula Record (MFR) A Master Formula Record (MFR) is a controlled document that serves as a blueprint for manufacturing a pharmaceutical product. It ensures product quality, consistency, and compliance with regulatory requirements. 🔑 Key Steps...
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 18, 2025
FDA Warning Letters for Cleaning Validation The FDA frequently issues Warning Letters to pharmaceutical manufacturers for deficiencies in cleaning validation programs, as inadequate cleaning can lead to cross-contamination, adulteration, and patient safety risks....
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...
