MHRA publishes revised Pre-Inspection report and Interim Compliance report guidance

MHRA has published its revised guidance for Pre-Inspection report and Interim Compliance report in March 2015. In revised documents a section on data integrity and a requirement to list molecules handled have been added. MHRA asks in the above mentioned documents whether the manufacturing site has a policy on data integrity/governance. In addition the MHRA asks for any major changes made to the IT (Information Technology) systems and for new IT systems in use. Moreover, the document requires listing of all principal computerized systems. The agency asks for the type of IT system, the area in which the IT software is used, the name of the product and supplier, the version of the software and even the last qualification date and any modification, updates and patches performed.

These two documents are part of the risk based inspection system of the GMP Inspectorates in the UK. These documents are intended to help MHRA to get information prior to GMP inspection.

In the Pre-Inspection Compliance Report the MHRA asks for specific information prior to a GMP Inspection while the Interim Compliance Report should be submitted by sites between inspections following significant changes or in case the inspector requests and Interim Compliance Report from the manufacturing site. The Inspector will use the provided information to decide on the frequency of the inspections.