by Dr. Yashashwini Reddy | Sep 15, 2025
Guide to Inspections of High Purity Water Systems 1. Introduction High Purity Water (HPW) systems, including Purified Water (PW), Water for Injection (WFI), and Highly Purified Water (HPW), are critical utilities in pharmaceutical manufacturing. Regulatory agencies...
by Dr. Yashashwini Reddy | Sep 15, 2025
📘 Guidelines for Preparation of Site Master File (SMF) The Site Master File (SMF) is a regulatory document that provides detailed information about a pharmaceutical manufacturing site, operations, and quality management system. It is required by WHO, EU GMP (Annex...
by Dr. Yashashwini Reddy | Sep 15, 2025
Self-Inspection and Quality Audits in Pharmaceuticals 1. Self-Inspection Definition: An internal examination carried out by the company itself to evaluate compliance with GMP, SOPs, and regulatory standards. Purpose: Detect deficiencies in the quality system. Verify...
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...
