Qualification

Direct-impact systems are formally qualified — installation, operational, and performance qualification against pre-defined acceptance criteria — and released for GMP use. The acceptance-and-release decision lives here.

Purpose

Verify and document that direct-impact systems are fit for their intended GMP use, and release them for use.

Work performed

• Author and approve qualification protocols (IQ/OQ/PQ) with pre-defined acceptance criteria
• Execute installation, operational, and performance qualification against those criteria
• Investigate and resolve deviations, then compile qualification summary reports
• Make the acceptance-and-release decision for GMP use (EU GMP Annex 15)

Who is involved

• Qualification/validation engineers and system SMEs
• Quality Assurance approving protocols, deviations, and release
• Automation/CSV for computerised-system qualification (GAMP 5)

What quality owns

• Approval of qualification protocols, deviations, and acceptance criteria
• The system release / acceptance-and-release decision that permits GMP use

What engineering owns

• Execution of IQ/OQ/PQ and generation of the qualification evidence
• Technical resolution of qualification deviations

What operations owns

• Participation in performance qualification under representative conditions
• Confirmation that the qualified system is operable for routine use

Management decisions

• Acceptance of qualification completion and residual risk
• Prioritisation of deviation closure against the start-up date

Deliverables

• Approved IQ/OQ/PQ protocols and reports
• Deviation records and their resolution
• System release / qualification summary

Evidence to retain

• Executed qualification protocols and summary reports
• The release decision and its supporting acceptance-criteria results

Common risks

• Acceptance criteria set after results are seen, undermining the qualification
• Deviations closed without genuine resolution
• Leverage of commissioning evidence not justified, weakening the qualification

Gate criteria to advance

• Approved qualification protocols with pre-defined acceptance criteria
• IQ/OQ/PQ executed, deviations resolved, results meet criteria
• System release / acceptance-and-release decision by quality

Expensive if deferred

• Pre-defined acceptance criteria — criteria written to fit results are an inspection finding
• Deviation resolution — an unresolved qualification deviation blocks release and slips start-up

Business effect

The gate that permits GMP use; a weak qualification is the finding an inspector pulls first and the reason a start-up date slips.

Greenfield vs brownfield

Brownfield qualification is scoped by change impact against the existing validated state — often a focused requalification — whereas greenfield qualifies every direct-impact system from scratch.