Background
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 the MHRA.
It is considered that the scope, frequency and depth of inspections should be dependent on how the regulated organisation takes responsibility for compliance with the regulations. Whilst 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.
Good Manufacturing Practice (GMP) - Risk-based inspection process
The GMP risk-based inspection process commences for all participating sites on 1 April 2009. Participating sites are those UK sites that hold a manufacturing authorisation (MIA, MS, MIA [IMP]) and third Country sites that are named on a UK marketing authorisation or where UK has been the reference member state on a decentralised procedure.
Risk -based inspection risk rating statistics as of 27 April 2011
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Compliance report and interim update
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. A guidance document and example reports are also available to assist completion. The Compliance Report should be returned to your inspector prior to the inspection.
Following a site’s first inspection post 1 April 2009, it is expected that relevant changes affecting the site will be advised to the MHRA on a Compliance Report Interim Assessment. This form is available on the right hand side of this page for download and the guidance document for the Compliance Report applies. Instructions for return are contained on the form.
Risk rating process
The inspection process will be largely indistinguishable from the one 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 two-three years before all sites will have been formally assessed.
It is important to remember that the issue of a certificate of GMP compliance and/or support of the site on the relevant license is an indication of meeting the minimum level of GMP 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 the MHRA. Risk ratings can change following inspection resulting in either increased or decreased risk. Inspection risk ratings will not be published by the 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 a GMP Operations Manager or a GMP Expert Inspector. The 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 in the first instance.
Any questions or comments on risk-based inspection should be addressed to your inspector in the first instance.
Interim review
The GMP Inspectorate has completed a post-implementation review of the risk-based inspection (RBI) process. The presentation, which was originally presented at the MHRA GMP Symposium in November 2009, provides a summary of the key learning points and risk rating statistics to date.
GMP risk-based inspection process: Six months in, a half term review (1759Kb)
