In October 2015 the MHRA was audited under the Joint Audit Programme (JAP) for EEA GMP Inspectorates.
The audit programme is sponsored by the Heads of Medicines Agencies (HMA) and is focused solely on GMP, with management of the programme run by the Compliance Group which meets at the EMA and is supported by EMA staff.
The two main drivers for the process are to verify equivalence and consistency of the implementation of European legislation and the practical application of GMP standards by national inspection agencies across the EEA and also to preserve confidence in the equivalence of EEA GMP systems to all member states and to EU Mutual Recognition Agreement (MRA) partner countries. The evaluation checklist adopted for the audit were borne out of the MRA with Health Canada, and these have been adopted by both HMA’s JAP and PIC/S (Pharmaceutical Inspection Cooperation Scheme) audit programme.
More details on the process can be found on the EMA website
The audit, from 12th to 16th October, was conducted by a team of 3 assessors; the assessment team consisting of senior inspectors from Finland, France and Spain. The audit was also observed by USFDA whose focus was on the JAP process itself rather than GMP systems within the MHRA. The observers were taking part under the Mutual Reliance Initiative looking to establish equivalence between Europe and US – more on this in a later blog post.
This was a full scope re-audit, covering:
1: legislative and regulatory: requirements and scope
2: regulatory directives and policies
3: GMP standards
4: inspection resources
5: inspection procedures
6: inspection performance standards
7: enforcement powers and procedures
8: alert and crisis systems
9: analytical capability
10: surveillance programme
11: quality management system
The detailed inspectorate processes and practices in the MHRA, associated with the headings above, were assessed with the aid of a checklist of 78 indicators plus an EC legislation transposition guide.
The audit, as is normal practice, also included 2 on-site MHRA GMP inspections being observed, utilizing the JAP guidelines that describe the items normally necessary to initiate, plan, conduct, report upon and follow-up an observed inspection.
The 5 day audit required considerable resources from within the Agency, including the 2 on-site GMP inspection teams and those areas that support the inspectorate including Human Resources, Defective Medicines Report Centre, Inspectorate Policy, Inspection Action Group, Enforcement, the Licensing Authority, NIBSC, Medicines Testing scheme (including LGC)
How was it for you ?
It had been some time, 9 years, since the last JAP audit of the MHRA, and most of the current team were not directly involved last time around. So whilst we are very well aware of the responsibility we have when performing inspections, hosting an audit felt like a new experience. A negative outcome would have a significant impact on the functioning of the inspectorate and the reputation of the Agency. No pressure then!
We had a 6 month preparation period, collecting the evidence, organising the inspections, and completing the self-assessment report that would be the basis of the audit. This included a significant amount of time mapping the EU Regulations and Directives to the UK medicines legislation to show that all had been transposed sufficiently.
For the on-site audit, as hosts we wanted to ensure openness and transparency and so took the decision to present our evidence to the auditors by accessing our systems in the ‘live’ environment rather than downloading information and presenting offline. As the audit lasted 5 days there was a significant interrogation of the systems, and one or two ‘oops’ moments, but the lead auditor formally commending us for this approach.
At the close out meeting the assessment team confirmed that out of 78 indicators 73 were deemed to have been met with the other 5 deemed partially met. As a result of subsequent correspondence the assessment team concluded that ‘On the basis of the audit performed from October 12th to 16th, 2015, where equivalence has been demonstrated, the audit team is proposing that the Compliance Group considers the MHRA compliant with the JAP requirements.
Based on this positive JAP outcome, the FDA started its assessment of MHRA. This was the first assessment of an EU member state for the Mutual Reliance Initiative. This assessment is now complete and the FDA’s outcome is awaited….
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