Over the past three years, in the UK there have been significant developments in inspection risk management and the strategies of a number of regulators were reviewed by MHRA.
In this section...
Background
It is considered that risk-based inspections are dependent upon the regulated organisation taking responsibility for compliance with the regulations. While the company or organisation has always had legal responsibility for compliance, the notice of inspection has for some been a trigger for compliance assessment instead of a continuous compliance programme being in place.
Following a detailed review of risk-based inspection models used by a range of organisations, a draft model was designed to cover all GxP inspections, however, at implementation it is envisaged that there will be a different emphasis within the individual elements as appropriate to the different GxPs.
Risk-based inspection process
The GDP risk-based inspection process commences for all holders of Wholesale Dealers Licenses on 1 April 2009.
Update on risk-based inspection risk rating statistics from 1 April 2009 - 21 June 2010
Full WL holders
Total number of inspections put through risk system - 602
Number of re-inspections at (maximum) four year frequency - 366 (60.8 %)
Number of inspections at three year frequency - 180 (29.9 %)
Number of inspections at two year frequency - 32 (5.3 %)
Number of inspections at six month frequency - 24 (4.0%)
GSL only holders
Total number of inspections put through risk system - 19
Number of inspections at (maximum) six year frequency - 19 (100%)
Compliance report
Sites will be required to complete a Compliance Report in advance of inspection, this will be prompted by the inspector and these can be found on the right hand side of this page for download. Guidance to completing the report can be found within the document. The Compliance Report should be returned to your inspector prior to the inspection.
Risk rating process
The inspection process will be largely indistinguishable from that operated in recent years and will conclude as usual with a closing meeting where findings are verbally reported to site contacts. Inspectors will discuss the submitted compliance report at the opening meeting as they would have done previously with changes advised.
The inspector will use the inspection outputs along with a number of other factors to identify a risk rating for the site, this will in turn equate to a future inspection frequency. As this process is not concluded until the inspection is closed the risk ratings will not be discussed at the closing meetings. However a copy of the full inspection report which includes the full risk rating rationale will be provided to sites once the inspection has been closed.
As the process is being introduced on a rolling basis it will be three years before all sites will have been formally assessed.
It is important to remember that support of the site on the relevant license is indication of meeting the minimum level of GDP compliance. Risk ratings identify the degree of surveillance required within the licensing and inspection program. There is no intention that sites be rated against each other as a result of risk ratings assigned by MHRA. Risk ratings can change following inspection resulting in either increased or decreased risk. Inspection risk ratings will not be published by MHRA.
There will be no formal process of appeal against risk ratings and future inspection frequency. However any rating that results in an increased inspection frequency from the previous standard will be peer reviewed before conclusion by an GDP operations manager. MHRA does have a formal complaints process if sites wish to log an issue, however any concerns regarding the inspection process should be raised with the inspector.
Any questions or comments on risk-based inspection should be addressed to your inspector in the first instance.
Interim review
The GDP Inspectorate has completed a post-implementation review of the risk-based inspection (RBI) process. The presentation, which was originally presented at the MHRA GDP Symposium in November 2009, provides a summary of the RBI process and risk rating statistics to date.
Good Distribution Practice: GDP risk assessment strategy
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