PQ Documents definition
Examples of PQ Documents in a sentence
This group has coordinated an initial, informal audit by Roche of the PDL manufacturing facility project following mechanical completion, which included a review of the Impact Assessment, the System Boundary Drawings, the Commissioning Documents, and sample IQ, OQ, and PQ Documents (which is consistent with the ISPE Baseline Guide for Commissioning and Qualification Activities, the qualification approach currently being applied by PDL).
This audit should be performed following mechanical completion [*], and include a review of the Impact Assessment, the System Boundary Drawings, the Commissioning Documents, and sample IQ, OQ, and PQ Documents; which is consistent with the ISPE Baseline Guide for Commissioning and Qualification Activities (the qualification approach currently being applied by PDL).
Such bidders shall submit these documents in addition to the documents specified in the PQ Documents to meet Experience Criteria.