It's now just over 2 months since we started re-posting to the MHRA Inspectorate blog following the end of the pre-election period.
Over this time we have added 7 new posts covering a range of topics.
We hope you find this bite size approach to our recent posts useful.
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In this follow-up post we concentrated on the application of Annex 16 to Investigational Medicinal Products (IMPs)
This post was aimed at new applicants who are establishing a small wholesale dealers’ operation.
The GDP Inspectorate often receive queries from wholesaler distributors asking in what instances agreements are required between MAHs and wholesale distributors for the purposes of fulfilling pharmacovigilance requirements. The GPvP Inspectorate provides some clarification in this post.
We recently published the 1st April 2015 to 31st March 2016 GCP Inspection metrics report.
This post highlights this publication and notes that during the metrics period a total of 102 GCP inspections were undertaken by the GCP Inspectorate.
The collation of the 2015 inspection metrics data highlighted some common themes. This post shared these examples to help organisations to identify if these issues could occur at their own facilities and allow them to pro-actively improve compliance.
The use of unannounced inspections allows us to investigate issues that pose a significant risk to public health without obstruction and to work efficiently. We spend a lot of time planning and scheduling inspections and this post covered times when unfortunately things don’t go to plan.
This post described the main issues seen when freezers are used by pharmaceutical wholesalers and provided a GDP inspectors’ view on possible ways to address them.
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