28/29 October 2020
The MHRA has published a revised set of documents which are part of the risk based inspection system of the GMP Inspectorates in the UK. The MHRA has established a system in which companies have to fill out documents about their current compliance status. These documents are intended to help MHRA to get information prior to an inspection (in order to make a risk based decision about the frequency of performing GMP inspections) and in order to get information from the companies if any major changes take place at the manufacturing site. The two documents are called
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. The revision of the Pre-Inspection Report and Interim Compliance Report Guidance published in March 2015 will introduce two new requirements. A section on Data Integrity and a requirement to list molecules handled have been added. Interestingly, the 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 systems and for new IT systems in use. Moreover, the document requires to list all "principal" computerized systems (e.g. ERP, LIMS, MES). 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.
The Interim Compliance Report must be reported by any site which has been inspected by MHRA since 1 April 2009. The reports should be completed by each site holding or named on a UK manufacturing license, sites holding a Blood Establishment Authorisation, API sites, or non UK sites that are named on a UK Product License. The document has to be sent to the inspector who has performed the last inspection of the concerned site. Any failure to submit the Interim Compliance notification of change may lead to a higher risk ranking by MHRA.