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.
Posted by Dr. Tim Sandle, Pharmaceutical Microbiology
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