Equipment Qualification in Pharmaceutical Industry: DQ, IQ, OQ, PQ, URS & GMP Requirements
Published by: Pharma Quality System Editorial Team • Editorial basis: FDA drug CGMP and process-validation guidance, ICH Q7, Health Canada GUI-0001 and GUI-0029, and EU GMP Annex 15 URS • DQ • FAT/SAT • IQ • OQ • PQ • REQUALIFICATION Equipment qualification is the documented lifecycle used to show that pharmaceutical equipment is suitable for its intended GMP use, installed correctly, operates within defined ranges, and performs effectively under the conditions in which it will actually be used. Quick answer A common qualification lifecycle starts with User Requirements Specification (URS) , then progresses through Design Qualification (DQ) , appropriate vendor/site acceptance activities such as FAT/SAT , Installation Qualification (IQ) , Operational Qualification (OQ) , and Performance Qualification (PQ) . The exact structure should be risk-based and appropriate to the equipment and its intended use; some stages may be ...