MHRA is requesting that all manufacturing sites inspected after April 1, 2009 under its risk-based inspection (RBI) approach submit interim updates to communicate significant changes between inspections.
MHRA put its RBI effort in place following public consultation that began in late 2007 (IPQ, Jul./Aug. 2008). The guidance, instructions, updated report on the RBI effort, and form which must be filled out for the interim updates were published as part of the announcement. Affected sites are those UK sites that hold a manufacturing authorization for finished products and investigational medicinal products, and third-country sites that are named on a UK marketing authorization or where UK has been the reference member state on a decentralized procedure.
Sites will be required to complete a “compliance report” in advance of advance of being inspected – this will be prompted by the inspector. Additional information is available on the MHRA site. The compliance report should be returned to the inspector that last inspected the site prior to the inspection.
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.
[Editor’s note: The June 2010 issue of IPQ will provide an in-depth analysis of GMP/inspection and enforcement activity in the EU, US, and globally.]
Links for this story:
MHRA Guidance for completing API interim reports
Guidance for completing site compliance and interim reports
Site compliance and interim report form
MHRA report on progress on the initiative, April 2010
Example forms and additional information on the MHRA web site