by Dr. Yashashwini Reddy | Sep 18, 2025
📌 Lux (Light Intensity) Standards in Pharma Industry Light intensity in pharmaceutical facilities is crucial for ensuring product quality, safety, and compliance with cGMP and cleanroom requirements. It is measured in lux (lx), which represents lumens per square...
by Dr. Yashashwini Reddy | Sep 18, 2025
📌 List of Engineering & Utility Equipment in Pharmaceuticals 🔹 Water Systems Purified Water (PW) Generation & Distribution System Water for Injection (WFI) Generation System (Distillation, Multi-effect distiller, Vapor compression still) WFI Distribution Loop...
by Dr. Yashashwini Reddy | Sep 18, 2025
📌 Importance of Differential Pressure in Pharmaceuticals Prevents Cross-Contamination Differential pressure ensures controlled airflow between cleanrooms of different classifications. Positive pressure in cleaner areas prevents entry of dust, microbes, and...
by Dr. Yashashwini Reddy | Sep 18, 2025
1. Objective Demonstrate that the proposed purified water generation and distribution system is designed, specified and documented such that, when built and operated as designed, it will consistently produce Purified Water that meets USP requirements and is suitable...
by Dr. Yashashwini Reddy | Sep 15, 2025
📘 Preparation of Annual Product Review (APR) The Annual Product Review (APR) (also referred to as Product Quality Review – PQR in EU) is a regulatory requirement under 21 CFR 211.180(e) and ICH Q7/Q10. Its purpose is to ensure product quality, process consistency, and...
