C&Q

Commissioning and Qualification

Traditional C&Q ran commissioning as an engineering activity and qualification as a separate quality activity — which meant the same system got tested twice, once by engineers and again for the regulator, with the second pass adding paperwork rather than assurance. ASTM E2500 reframed it: one integrated, risk- and science-based verification programme, in which quality-critical aspects get the scrutiny and everything else is handled as Good Engineering Practice.

The pivot is the system risk assessment. Starting from the user requirements and the product’s critical quality attributes, you determine which systems and which aspects of them actually affect product quality — the critical aspects — and concentrate verification there. Subject matter experts, not a compliance department in isolation, decide what constitutes adequate evidence, and quality approves the approach and the outcome.

The practical prize is leverage. Vendor documentation, factory and site acceptance testing, and commissioning results can all count as verification evidence when the supplier has been assessed and the testing was performed under adequate control — instead of being repeated verbatim as IQ/OQ. Done properly this shortens schedules and improves assurance; done as a paperwork exercise it just relabels the same duplication.

• —One integrated verification programme, not commissioning then a duplicate qualification.
• —System risk assessment identifies critical aspects traceable to the product’s CQAs and the URS.
• —Effort concentrates on quality-critical aspects; the rest is Good Engineering Practice.
• —Subject matter experts define adequate evidence; quality approves approach and outcome.
• —Leverage vendor documentation and FAT/SAT as evidence where the supplier is assessed and control is adequate.
• —Ends in a verified, released system with a defined requalification and change-control path.

ASTM E2500-20 (Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment); ISPE Baseline Guide Vol. 5, Commissioning and Qualification (2nd ed.); EU GMP Annex 15 (2015) for the qualification expectations it must satisfy.