Contract manufacturing · MIA holder
Closing MHRA inspection deficiencies and passing a clean re-inspection
A UK contract manufacturer received significant deficiencies at a routine MHRA GMP inspection that put its manufacturing licence at risk. Acting as contract Qualified Person and lead auditor, we built and drove the remediation, then prepared the site for a re-inspection it passed with no critical findings.
Challenge
A routine MHRA inspection of a UK MIA holder closed with several major findings across deviation management, CAPA effectiveness and data integrity. The deficiencies carried a firm response deadline and, left unresolved, put the manufacturing licence and ongoing supply at risk. The internal quality team was small and already stretched, with no spare capacity to run a full remediation while keeping production going.
Approach
We began with an independent gap assessment against EU GMP Part I and the relevant annexes, mapping every finding to a root cause rather than a symptom. From that we authored a single, prioritised CAPA plan with clear owners and realistic dates, and project-managed it to closure. The core work was rebuilding the parts of the Pharmaceutical Quality System that had failed: tighter deviation triage, CAPA closed on evidence of effectiveness, and audit-trail review built into routine practice. In the final weeks we ran a mock inspection so the team could rehearse hosting, and we acted as Qualified Person through certification.
Outcome
The site closed every deficiency within the MHRA timeframe and passed its re-inspection with no critical findings, retaining the licence and protecting supply. Just as important, the quality system that came out of the work was leaner and more defensible than the one that went in, so the improvements held at the next routine inspection.