by Dr. Yashashwini Reddy | Sep 15, 2025
GMP Audit Checklist – Storage of Starting Materials 1. Storage Area Design & Conditions Is the storage area clean, well-lit, pest-free, and secure? Are temperature and humidity continuously monitored and recorded? Are conditions maintained as per material storage...
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
FDA Forms Generally Used in Pharmaceutical Inspection 1. Form FDA 482 – Notice of Inspection Issued at the start of an inspection. Notifies the company that FDA investigators are officially beginning the inspection under the authority of the FD&C Act (Section...
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...
by Dr. Yashashwini Reddy | Sep 13, 2025
1. Equipment Design & Installation Equipment designed with GMP-compliant sanitary design (easy to clean, non-reactive materials). Materials of construction suitable (e.g., SS 316L for product contact). Installation Qualification (IQ) completed and documented....
