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It is a “GMP” requirement of good manufacturing practice that each manufacturer identifies what validation work is necessary to prove control of the critical aspects of their particular operation.
Comecer supplies FAT (Factory Acceptance Test) protocol validation for every Hot Cell/Dispensing system/Isolator.
Comecer performs SAT (Site Acceptance Test) and supply if request IQ & OQ protocols (Installation Qualification & Operational Qualification)
The validation protocols comply to the following standards: