cGMP Compliance · 7 min read

Preparing for a GMP Inspection: Gap Assessment to Verification

A five-stage approach to audit readiness, remediation planning and sustaining a culture of quality.

Inspection readiness is a programme, not an event. A staged approach keeps the work proportionate and makes the result durable.

Five stages

  1. Gap assessment: compare current practice with the applicable GMP standard and rank the findings by risk.
  2. Remediation plan: assign owners, deadlines and the evidence that will show each gap is closed.
  3. Implementation: update procedures, train people and fix equipment or facility issues.
  4. Verification: a mock inspection that tests whether the fixes work in practice.
  5. Sustain: self-inspections, management review and trend monitoring so quality does not drift.

Culture over paperwork

Inspectors can tell whether quality belongs to a department or to the whole site. Visible management ownership, honest investigations and procedures that match practice do more than a polished document set.

ECP supports each stage, from the first gap assessment to the mock inspection, for manufacturers across Africa.

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