Reference 2019-31

REF:           2019-31

Subject:       MHRA inspection

 

Request:

  1. What was the date of the Trusts last Medicines and Healthcare Products Regulatory Agency (MHRA) inspection?
  2. Did this inspection include a review of the Laboratory Information Management System (LIMS) validation?

 

Response:

1. What was the date of the Trusts last Medicines and Healthcare Products Regulatory Agency (MHRA) inspection?

 

The blood transfusion laboratory has never been inspected by the MHRA. We submit a compliance report annually in April; the analysis of the report by the MHRA would then trigger an inspection under the regulations. To date, our compliance report has always been deemed satisfactory, with no requirement for an inspection.
2. Did this inspection include a review of the Laboratory Information Management System (LIMS) validation? Unable to comment as no experience of MHRA inspection.