Commissioning & Qualification: an integrated approach to bringing plants online and qualifying them

Between technical commissioning (Commissioning) and regulatory qualification (Qualification) there is traditionally a break point, and with it a great deal of duplicated effort. An integrated C&Q approach closes this gap.

From sequential to joined-up working

The core idea behind ASTM E2500 and the revised Annex 15: tests are planned cleanly once and recognised as qualification-relevant wherever they concern critical quality attributes. Well-documented commissioning can thus feed directly into qualification (leveraging), instead of being repeated in IQ/OQ.

Criticality drives the depth

• Assess systems and components according to GMP impact.
• Plan tests on a risk basis: deep where critical, lean where non-critical.
• Use commissioning results for qualification in a traceable way.

What counts in the end: the handover

A successful C&Q does not end with a stack of protocols, but with a plant that is handed over ready for operation, for the next shift and audit cycle. This is precisely where it shows whether engineering and quality have truly worked hand in hand.

Well-planned commissioning is not a run-up to qualification: it is its first part.

Good Engineering Practice as the basis for leveraging

For commissioning results to be recognised in qualification, they must have been generated to a verifiable standard. The revised Annex 15 and ASTM E2500 require that supporting evidence is produced, documented and traceable in accordance with Good Engineering Practice. Only then can a commissioning test be adopted without being repeated in IQ or OQ.

In practical terms this means: test equipment is calibrated and traceable, acceptance criteria are defined before the test, and supplier documents from FAT and SAT are structured so that they can be referenced later. Without this foundation, the planned saving quickly turns into duplicated work.

An end-to-end traceability approach links requirements, risk assessment and testing. Every critical requirement can thus be traced through to its evidence, and qualification rests on a robust chain rather than on loose individual documents.

Typical mistakes in C&Q projects

• Acceptance criteria are only formulated during the test and can no longer be assessed objectively.
• The criticality assessment is inconsistent, so that non-critical systems are tested too deeply and critical ones too leanly.
• Commissioning protocols do not meet the documentation requirements and therefore cannot be leveraged.
• The calibration status of the test equipment is not evidenced, so the measured values lose their evidential value.
• Change control takes effect too late, so that design changes do not feed back into the test planning.

Practical check points before handover

It is before handover that it is decided whether the plant is truly ready for operation. A structured review that brings together the technical and regulatory perspectives is advisable, rather than simply ticking off protocols.

• All deviations are assessed, documented and either closed or accompanied by a justified action plan.
• Test evidence satisfies ALCOA+, that is attributable, legible, contemporaneous, original and accurate, including for electronic records under Annex 11 and 21 CFR Part 11.
• As-built documentation, SOPs and training records are available for operations.
• The open items list is prioritised and responsibilities are clearly assigned.

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