Risk-based Inspection Programme - a Model for Future Inspections?

  
The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has recently issued a proposal for implementing a revised risk-based inspection programme for Good Practice inspections of manufacturers and/or importers and wholesale distributors of medicines for human use (GMP/GDP), manufacturers and/or importers of investigational medicinal products and contract research organisations (GMP and GCP), pharmacovigilance practices (GPvP) and good laboratory practices (GLP), known collectively as Good Practices (GxPs) and sought views of the stakeholders.

An overview of the responses has now been published. The document serves to summarise the responses received from the public following the MHRA consultation.

The purpose of the consultation was to seek comments on the MHRA's proposal for implementing a revised risk-based inspection programme for Good Practices, based on the principles

• Inspection;
• Corporate Compliance;
• Self assessment;
• Intelligence;
• Risk Profile and
• Risk Assessment

and to establish a Risk Management Review Board which would validate the risk category assigned to an organisation.

Although currently not of any regulatory impact for other EU Member States, the document is a good source of information for those interested in questions like:

• Do you agree that regulatory inspection requirements should be based on risk to public health and that non compliant organisations should carry a greater inspection burden?
• Will the introduction of risk-based inspections achieve savings for your business or industry sector?
• Would the introduction of a risk-based inspection programme have any negative impact on your business or industry sector?

Altogether the Consultation Letter invited responses to 14 questions on the proposed risk-based inspection model. The model is supposed to be used to prioritise inspection requirements of the MHRA. Maybe it will lead the way for further European developments and changes to current inspection practice.

Prepared by:
Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)