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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Annex 16, QP Certification and Batch Release – Frequently Asked Questions – part 2In this follow-up post we concentrated on the application of Annex 16 to Investigational Medicinal Products (IMPs) |
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Creating written procedures for new applicants for Wholesale Dealer Authorisations (WDA)This post was aimed at new applicants who are establishing a small wholesale dealers’ operation. |
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Do wholesale distributors require pharmacovigilance agreements?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. |
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Good clinical practice inspection metrics for 2015 to 2016 publishedWe 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. |
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GLP Inspections metrics reflectionsThe 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. |
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An Inspector Calls: Part 1, GMP Short Notice and Unannounced InspectionsThe 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. |
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Use of freezersThis 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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2 comments
Comment by Annette Walsh posted on
This is just an idea for a blog as there are thousands of WDA holders and only about 50 members of HDA who are representing the sector.
MHRA circulates a monthly FMD Safety Features Newsletter – its aim is to keep stakeholders posted on the latest developments with implementation. If you don't currently receive a copy of the newsletter and would like to, please email the FMD mailbox above with the following – your name, your organisation (if applicable) and your title (if applicable).
Comment by Mark Birse posted on
Annette,
Thank you for your suggestion.
The FMD mailbox can be reached at - FMD.safetyfeatures@mhra.gov.uk
Regards,
Mark