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
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
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...
