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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)
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