Qualification in Pharma
STEP 1: User Requirement Specification (URS): List of all requirements of buyer regarding the equipment to be purchased STEP 2: Design Qualification: Document Verification that proposed design of the equipment is suitable for intended purpose. STEP 3: Factory Acceptance Test (FAT): After completing of DQ of new equipment generally, inspection is done by the user before the delivery at the site is called the FAT.
STEP 4: Site Acceptance Test (SAT): The objective of the site acceptance test is to validate that the control and safety systems are full operational in accordance in accordance with their functional specifications prior to using them to operation the processing unit. STEP 5: Installation Qualification (IQ): Ensures that equipment is installed correctly, adhering to predetermined specification and the manufacturer's recommendation. STEP6: Operational Qualification (OQ): Involves testing the equipment to confirm that it operates as intended, within operating ranges approved by the manufacturer. STEP 7: Performance Qualification (PQ): Establishing confidence through appropriate testing that the finished product or process produced by a specified process meets all release requirement for functionality and safety and that procedures are effective and reproducible.