by Dr. Yashashwini Reddy | Sep 16, 2025
1.0 Purpose To establish a procedure for the safe, compliant, and documented disposal of expired finished goods in order to prevent unintended use, ensure environmental safety, and maintain regulatory compliance. 2.0 Scope This SOP applies to all expired, damaged, or...
by Dr. Yashashwini Reddy | Sep 15, 2025
Internal Audit / Self-Inspection Checklist (Defects & Regulatory Compliance Focus) 1. Documentation & Records Are SOPs, policies, and work instructions up-to-date, approved, and controlled? Is there evidence of uncontrolled or obsolete documents in use? Are...
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
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
Preparation for GMP Audit in Pharmaceuticals Good Manufacturing Practice (GMP) audits are crucial checkpoints that ensure pharmaceutical companies comply with regulatory standards (FDA, EMA, MHRA, WHO). Proper preparation reduces the risk of critical observations and...
