News
MHRA GDP Pilot Scheme - OBERA: Office Based Evaluation and Risk Assessment programme
The Medicines and Healthcare products Regulatory Agency (MHRA) is trialling remote assessment of some distribution facilities which would impact holders of a Wholesale Dealer’s Licence (WDA(H)) whose main activities operate from a head office supplied from a number of ‘satellite’ facilities. For the companies selected, their satellite sites will be assessed remotely using information provided by the company in a standardised format.
26th April 2019
For the pilot, the United Kingdom’s MHRA plans to contact companies with more than 100 sites. Through gateway inspections similar to the standard GDP review, MHRA will assess whether these companies are eligible to participate in OBERA. The criteria assess the activities and independence of satellite sites.
The Gateway Inspection will establish whether the company is suitable for participation in the scheme.
The inspection will follow the standard GDP inspection format and be chargeable as such. The inspector(s) will focus on aspects of GDP that relate to the business model being operated.
It is expected that the company will have documented, and have available for inspection, an overview of the processes used in their stock transfer model and that it will be clearly defined which aspects are handled on behalf of the sites by the head office.
Typically, these would include recall co-ordination, aspects of the quality management system (QMS), transport provision and, for some models, centralised ordering. The precise functions will vary from company to company.
Depending on the size and complexity of the operation, this Gateway Inspection may take longer than a single day.
Please refer to the full MHRA inspectorate blog here.