Tuesday, 9 July 2019

GDP Office Based Evaluation and Risk Assessment programme (OBERA)

The MHRA GDP Inspectorate is embarking on a pilot of a new inspection approach that will 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.

The Office Based Evaluation and Risk Assessment (OBERA) is targeted at companies that operate from a single head office location, where the majority of the wholesale activity takes place, with a number of satellite sites which perform a very limited range of GDP activity.

Inclusion in the programme will be dependent upon the head office of the company passing an on-site 'Gateway Inspection’.

For the purposes of the pilot, companies with over 100 sites on their Wholesale Dealer’s Licence will be allocated a Gateway Inspection first. These companies will be contacted shortly, with the Gateway Inspections scheduled to commence during spring 2019.

For further details, see MHRA - https://mhrainspectorate.blog.gov.uk/2019/04/16/introducing-the-gdp-office-based-evaluation-and-risk-assessment-programme-obera/

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

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