by Dr. Yashashwini Reddy | Aug 18, 2025
📌 Temperature and Humidity Validation/Mapping in Storage Area Overview:Temperature and humidity mapping is a critical activity in pharmaceutical warehouses, cold rooms, and storage areas to ensure that medicinal products are stored under controlled conditions as per...
by Dr. Yashashwini Reddy | Aug 18, 2025
Why Firms Must Avoid FDA 483 and Warning Letters? Pharmaceutical, biotechnology, and medical device firms must avoid FDA Form 483 observations and Warning Letters because they indicate serious compliance failures that can harm business operations, reputation, and...
by Dr. Yashashwini Reddy | Aug 18, 2025
Purpose of Process Validation in Pharmaceuticals Process validation is a documented evidence-based approach that ensures a manufacturing process, when operated within established parameters, can consistently produce pharmaceutical products meeting predetermined...
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 12, 2025
Sampling and Testing in Exhibit and Process Validation Batches 1. Introduction Exhibit Batches: Produced at commercial scale (or pilot scale in some cases) before product launch, used to demonstrate manufacturing feasibility and generate stability, quality, and...
