The MHRA are continuing with the risk based programme for the inspection of contract testing laboratories used by UK manufacturers license holders.
An original proposal that the laboratories undertake a self assessment has been reviewed and is now considered to be inappropriate as it was not seen to reduce the regulatory burden over the existing system.
New proposals place the emphasis on changes made in testing since the last inspection (details of this should be held in the technical agreement between the license holder and contract laboratory), this will be monitored and significant changes may trigger an inspection of the laboratory based on risk assessment.
A new form is to be completed by the license holder indicating any changes made to the contract testing on their behalf.
The only flaw in the system is there is no indication of what constitutes a “significant change” as the form includes facilities equipment and personnel as well as well as the tests, services and other GMP activities.
Details of these proposals are available on the following links: