by Dr. Yashashwini Reddy | Sep 20, 2025
1. Purpose To describe the procedure for performing and documenting Operational Qualification (OQ) of equipment, instruments, and systems to ensure they operate according to defined specifications and intended performance. 2. Scope This procedure applies to all...
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 19, 2025
Periodic Review and Requalification 1. Periodic Review Definition:A systematic review of facilities, utilities, equipment, and computerized systems at defined intervals to ensure they remain in a state of control and continue to comply with regulatory requirements....
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...
by Dr. Yashashwini Reddy | Sep 1, 2025
🧪 Qualification Procedure for Vial Washing Machine A Vial Washing Machine is a critical equipment in sterile manufacturing, ensuring removal of particulate and microbial contamination before sterilization and filling. Its qualification ensures consistent performance...
