In accordance with the recommendations of the Hampton Report, the MHRA is adopting regulatory strategies that minimise the burden on the regulated industry while maintaining the required levels of public safety.
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Background
In accordance with the recommendations of the Hampton Report, the MHRA is adopting regulatory strategies that minimise the burden on the regulated industry while maintaining the required levels of public safety.
Regulators should target their activities on those organisations or activities that pose the greatest threat to public safety. As part of this initiative, the regulatory activities of the UK Good Laboratory Practice Monitoring Authority (GLPMA) are based upon a ‘risk assessment process’ whereby the risk of failure to comply with the GLP regulations (and the specific requirements of the GLP Principles) and the potential hazard to public safety resulting from non-compliance are considered.
The consideration of risk and potential hazard are taken into account when determining the frequency and scope of GLP compliance monitoring inspections. The procedures adopted by the GLPMA have been developed in consultation with industry stakeholders.
The risk assessment process
On completion of an inspection, test facility management will be asked to respond to the GLP deficiencies that have been identified. When the response is received by the GLPMA it will be considered by the inspector to assess whether the proposed remedial actions are appropriate to correct the deficiencies raised.
Once the inspector is satisfied that all deficiencies have been addressed they will then conduct a risk assessment.
The risk assessment is primarily based upon the number, severity and nature of the deficiencies raised, and will take into account the detail and commitment evident in the response.
Other information concerning the activities of the test facility is also considered; this will include, but is not limited to, the volume of GLP work undertaken, the nature and purpose of the work etc. The outcome of the risk assessment will be a recommendation for the next inspection date, the duration and scope of that inspection.
Test facilities where only small numbers of less serious deficiencies were raised, can expect to be inspected at an approximate biennial frequency (unless other risk factors apply – eg significant volume of GLP work) and might be subject to an inspection of reduced duration that focuses on key aspects of their activities. Conversely, facilities at which critical or major deficiencies were raised can expect to be inspected at shorter intervals and to undergo a more rigorous inspection.
The duration and scope of these inspections will be determined by the nature of the deficiencies identified during the most recent inspection. Large facilities that conduct a high number of pivotal studies may be inspected annually regardless of whether serious deficiencies are identified.
Notification of changes within a GLP test facility
As indicated above, the primary risk assessment of a test facility is conducted after a compliance monitoring inspection has been conducted and test facility management has responded to any deficiencies raised. The recommendation for the date, duration and scope of the next monitoring inspection will have been based on information available to the inspector at that time.
To ensure that the date and scope of planned inspections remains appropriate to the test facility concerned, any significant changes that have occurred within the GLP test facility, or which are planned, should be notified to the GLPMA.
A standard form and guidance on its completion are available here:
Notification of change form 
(665Kb)
Guidance on completion of the form used to notify the GLPMA of changes within the GLP test facility
(51Kb)
The information provided in the change form is considered by the GLPMA to assess whether it presents an increased risk. If this information affects the previous risk assessment it could lead to a revision in the date, duration or scope of future monitoring inspections.
Should the GLPMA receive any other intelligence concerning a test facility, eg from other regulatory authorities, this information will be considered as described above.
