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...
by Dr. Yashashwini Reddy | Sep 13, 2025
GMP Audit Checklist – Personnel & Premises 1. Personnel 1.1 Organization & Staffing Adequate number of trained and qualified staff available. Organizational chart available and updated. Clear roles, responsibilities, and reporting lines defined. 1.2 Training...
by Dr. Yashashwini Reddy | Sep 13, 2025
Vendor Audit Checklist 1. General Information Vendor profile and organization structure available. Valid licenses, registrations, and certifications (GMP, ISO, GDP). Regulatory inspection history (FDA, EMA, WHO, local authorities). Change notification procedure in...
