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:
- ISO 14644 (Cleanrooms and associated controlled Environments)
- ISO 10648 (Containment enclosures)
- EEC-GMP (Good Manufacturing Practice – Annex 1 Manufacture of sterile Medicinal Products)
- PDA – TR Nr 34 (Design and Validation of Isolator Systems for the Manufacturing and Testing of Health Care Products)