by Dr. Yashashwini Reddy | Sep 20, 2025
1. Purpose To establish guidelines for maintaining personal hygiene of all personnel to ensure product safety, prevent contamination, and maintain a clean working environment. 2. Scope This SOP applies to all employees, contract workers, visitors, and service...
by Dr. Yashashwini Reddy | Sep 20, 2025
1. Purpose To establish a documented procedure to verify that the equipment/system has been properly installed according to manufacturer’s specifications, approved drawings, and regulatory requirements. 2. Scope This SOP applies to all new equipment, instruments,...
by Dr. Yashashwini Reddy | Sep 20, 2025
1. Purpose To verify and document that the equipment/system performs consistently and reliably under actual production conditions as per predefined specifications and acceptance criteria. 2. Scope This PQ is applicable to [Equipment/System Name] used in...
by Dr. Yashashwini Reddy | Sep 18, 2025
📌 Types of Water in Pharmaceuticals, Usage, and Preparation Techniques 🔹 1. Potable Water (Drinking Water) Usage: Base feed for preparation of Purified Water, WFI, and Clean Steam. Used for general cleaning (non-product contact). Preparation Technique: Obtained from...
by Dr. Yashashwini Reddy | Sep 18, 2025
📌 User Requirement Specification (URS) in Pharmaceuticals 🔹 Definition A User Requirement Specification (URS) is a document that clearly defines what the end-user expects from a system, equipment, utility, or software before procurement, design, or implementation. It...
