The UK pharmaceutical and life sciences industry requires equipment qualification as an essential component to achieve GMP compliance. Manufacturers deliver equipment together with Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) reports. The reports which organizations receive from vendors can bring useful information to their operations. However organizations have to determine the extent to which they can depend on vendor information when conducting IQ/OQ/PQ testing according to current validation standards, which include ASTM E2500.
Leveraging Validation Data Without Blind Reliance
The main principle of ASTM E2500 requires organisations to use risk-based qualification methods, while they should use validation data only when it is suitable. FAT and SAT results can support qualification by demonstrating that the equipment meets design and functional requirements. The data requires critical assessment because it should not be taken as trustworthy information. UK regulators expect manufacturers to demonstrate their use of vendor data, while they must prove their testing occurred in controlled conditions, which were documented in detail.
The Transportation Gap Between the SAT
The transportation gap stands as the primary restriction for the Single-Factory Acceptance Testing FAT testing process. Equipment that performs perfectly at the vendor site may behave differently after shipping, installation and reassembly. Environmental changes, together with mechanical stress and configuration changes, create risks which the FAT testing process does not identify. The complete FAT testing results become available for testing purposes, but SAT testing and on-site testing remain requirements.
Vendor Documentation and GDP Expectations
The vendor’s Good Documentation Practice (GDP) system directly affects the reliability of FAT and SAT reports. The testing results from vendors lose value when their results include incomplete protocols and missing raw data, and their testing procedure fails to maintain proper control of deviations. UK companies require vendor documentation audits to confirm traceability and data integrity while matching GMP standards before they use outside qualification results.
Avoiding Unnecessary Test Duplication
The main benefit of using FAT data is that it helps decrease unnecessary testing during IQ/OQ/PQ. Test skipping without proper risk evaluation creates compliance gaps in testing procedures. The testing process requires a balanced approach which matches FAT and SAT results to user needs while determining essential site tests that require retesting. The method supports ASTM E2500 by enabling organisations to achieve compliance through their efficient qualification processes.
FAQs
- Can the vendor perform my IQ/OQ?
Vendors can assist with IQ and OQ testing activities, but the licensed company must maintain all authority to approve tests and oversee their execution and ensure all tests meet regulatory requirements.
- What is the biggest risk in relying onFAT?
The major concern would be that, after transportation, installation and configuration at the site, the performance could not remain as it was.
- Does an FAT replace the need for anIQ?
No. The Factory Acceptance Test helps organisations meet their qualification needs, but their process requirements for Installation Qualification must be performed at their actual installation site.
