by Dr. Yashashwini Reddy | Sep 18, 2025
📌 Rotameter A Rotameter is a simple, reliable device used to measure the flow rate of liquids and gases in pharmaceutical, chemical, and other industries. It belongs to the variable area flowmeter family. 🔬 Principle of Rotameter Works on the variable area principle:...
by Dr. Yashashwini Reddy | Sep 16, 2025
1.0 Purpose To define the procedure for the correct operation of the sampling booth to ensure clean, contamination-free, and safe conditions during the sampling of raw materials and to prevent cross-contamination. 2.0 Scope This SOP is applicable for all personnel...
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...
by Dr. Yashashwini Reddy | Sep 15, 2025
Annual Product Quality Review (APQR/APR/PQR) in Quality Improvements 1. What is APQR/APR/PQR? Annual Product Quality Review (APQR), also known as Annual Product Review (APR) or Product Quality Review (PQR), is a regulatory requirement under ICH Q7, EU GMP Chapter 1...
by Dr. Yashashwini Reddy | Sep 15, 2025
Audit Trail Requirements in Pharmaceuticals An audit trail is a secure, computer-generated, time-stamped record that allows for the reconstruction of events related to the creation, modification, or deletion of electronic data. In the pharmaceutical industry, audit...
