Tandem has completed several recent commissioning and qualification projects for our pharmaceutical and biotech clients. Commissioning and qualification are verification activities which assure systems are fit for purpose and don’t pose a risk to product quality, safety, purity and efficacy.
Tandem’s risk based approach to verification complies with ASTM E2500-07. Tandem will capture the verification strategy in the Validation Project Plan. This will include a Risk Traceability Matrix which will be used to check URS parameters through the design documentation and test protocols.
Design reviews are conducted to ensure a fit for purpose design and FMEAs are used to determine the Critical Quality Attributes (CQAs) of each GMP system.
FAT/SAT/IV/FV protocols are used to test the CQAs of each GMP system and the IOQ reports are used to verify these by leveraging results from the test protocols.
Verification can be achieved through vendor documentation when the vendor has a proven quality system and when they demonstrate technical competence and adherence to GEP. Vendor capability is assessed by formal Supplier Assessment at enquiry stage.
Cycle development is used to define the operating parameters of the systems and is captured in Cycle Development reports. The cycle development results inform the PQ test protocols, the results of which will be captured in final PQ reports