13/14 December 2023
The U.K. Medicines and Health Products Agency (MHRA) is testing a new, office-based inspection process - without a visit of the site.
The pilot programme is known as OBERA (Office-based Evaluation and Risk Assessments) and is aimed at wholesale dealer's license holders (WDA(H)) who operate mainly from a single headquarter but have several small sites performing only a few GDP activities. The OBERA program serves as a supplement to the classical GDP inspections on site.
Basically it is an extension of the current MHRA's risk-based inspection program for the WDA holders and will free up inspector time. The questionnaire which will be used has been in use for some time and companies are obliged to complete them when requested and return to the MHRA.
The pilot project is accomplished first for companies with over 100(!) "satellite sites". In advance the head office must go through a so-called "gateway inspection" on site, which follows the usual GDP inspection format. Such a gateway inspection can take longer than one day. The focus here will also be on the Responsible Person (RP) for GDP, who must prove a good overview of the activities at the satellite locations and that these act in accordance with GDP.