MHRA Statement on Lab Inspections

MHRA Statement on Lab Inspections

Please see below for details on updates from the MHRA regarding labs using samples generated from CTIMP studies.

We have very limited information on this at present, but the update from the MHRA is as follows;

The MHRA conducts Statutory GCP Inspections in accordance with the UK Statutory Instrument 2004/1031 (the Medicines for Human Use (Clinical Trials) Regulations 2004) and subsequent amendments, and it is the intention of the MHRA GCP Inspectorate to conduct inspections of laboratories that perform the analysis or evaluation of human samples collected as part of a clinical trial.   This inspection programme will have a focus on analysis which is conducted in support of primary or secondary endpoint data and objectives or where the analysis is critical to the conduct of the trial (e.g. specific genetic mutations associated with eligibility assessments).  Routine sample analyses for safety testing e.g. standard panels of tests within clinical chemistry and haematology for example, are not the focus of this inspection programme.

The GCP lab inspection programme is new, and the MHRA have been approaching laboratories (commercial and non-commercial) to gather information in the first instance, and may contact labs in Edinburgh/Lothian in the near future.

See below for a guidance document from the European Medicines Agency regarding the requirements for laboratories that perform the analysis or evaluation of clinical trial samples.