“The concept of qualification for technical equipment is not new. Many suppliers have always conducted device checks. However, these qualification and validation-related activities have not been given due consideration.” (PIC/S – PI006). Numerous technical acceptance tests such as FAT (factory acceptance tests) are already conducted at the manufacturing plant independently of GMP. This continues with SAT (site acceptance tests) on the construction site after the equipment is set up and installed. Some tests are performed according to the manufacturer’s quality assurance system, others for documentation for a subsequent promise of guarantee.
The goal is to take GMP-related aspects into account at an early stage of qualification through timely coordination and targeted integration, thereby avoiding time lag.
Adaptation and Proper Use of FAT and SAT – Efficiency
Many FAT and SAT tests and checks are activities that are also demanded as part of a qualification in the IQ (installation qualification) and OQ (operational qualification) phases. So why do the work twice? Why repeat what professionals such as designers and manufacturers have already tested? When tests are coordinated in advance and the acceptance criteria, scope, form and content of the corresponding documentation are approved ahead of time, there simply is no reason! Such adapted FATs and SATs can then be referenced and the results integrated into the qualification, saving time and reducing costs. Efficiency.
Coordination is Crucial
Proper coordination between trades is the key to the beneficial integration of FAT and SAT. This is challenging enough, since complex projects usually involve numerous trades, suppliers and subcontractors. An understanding of GMP requirements is not always given. gempex conducts such coordination talks, moderates and makes recommendations. And designs workflows to ensure that essential test documents are on hand in a timely manner, reviewed against the GMP criteria, discussed and amended – GMP-compliant.
Integration: Support yes – Replace no
FAT and SAT activities can support and facilitate qualification, avoid duplicate work. But they cannot replace qualification – the keyword is integration. What this means is properly embedding qualification procedures and documents in a manner accepted by the authorities. gempex supports FAT and SAT activities as an independent party, records execution and results, or compiles such records. Subsequently gempex conducts the evaluation – as an independent GMP expert. That makes qualification significantly easier.
- avoiding duplicate work by integrating FAT/SAT results
- clearly structured workflows to ensure consistent execution
- documentation and integration in compliance with regulations
- support from an independent 3rd party
- verification of FAT/ SAT activities as the basis for a promise of guarantee