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 16, 2025
1.0 Purpose To establish a procedure for scheduling and conducting retesting of raw materials after the initial expiry/retest period to ensure continued compliance with specifications before use in manufacturing. 2.0 Scope This SOP applies to all raw materials stored...
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
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...
