Good distribution practice

International regulators inspecting in the UK

The MHRA has seen an increasing number of inspections being conducted in both the UK and the rest of the EU by regulators from other countries.

PIC/S - Press release and news of TFDA hosted meetings and seminar, September 2017

Posted by: Mark Birse, Posted on: 11 October 2017 - Categories: Compliance matters, Events and symposia, Good clinical practice, Good distribution practice, Good laboratory practice, Good manufacturing practice, Good pharmacovigilance practice

From 11 to 15 September 2017 I attended the PIC/S Committee meeting, Executive Bureau meeting, and Annual Seminar hosted by the Taiwan Food and Drug Administration (TFDA)

Missed our last few posts?

Posted by: Mark Birse, Posted on: 1 September 2017 - Categories: Compliance matters, Good clinical practice, Good distribution practice, Good laboratory practice, Good manufacturing practice, Good pharmacovigilance practice

A bite sized summary of our recent posting to the MHRA Inspectorate blog

Creating written procedures for new applicants for Wholesale Dealer Authorisations (WDA)

Posted by: Steve Todd, Posted on: 31 July 2017 - Categories: Compliance matters, Good distribution practice

Are you a new applicant establishing a small wholesale dealers’ operation; and do you need guidance for creating written procedures?

Do wholesale distributors require pharmacovigilance agreements?

Posted by: Tony Orme and Mark Birse, Posted on: 25 July 2017 - Categories: Compliance matters, Good distribution practice, Good manufacturing practice, Good pharmacovigilance practice

Our GDP inspectors often receive queries from wholesaler distributors asking in what instances agreements are required for the purposes of fulfilling pharmacovigilance requirements.

Use of Freezers

Posted by: Terry Madigan, Posted on: 20 June 2017 - Categories: Compliance matters, Good distribution practice, Good manufacturing practice

This post describes the main issues seen when freezers are used by pharmaceutical wholesalers and provides an MHRA GDP inspectors’ view on possible ways to address them.

Imported Unlicensed Medicines and Centrally Authorised Medicines intended for other EU Member States

Posted by: Mark Birse, Posted on: 30 March 2017 - Categories: Compliance matters, Good distribution practice, Good manufacturing practice

Previously, we have reminded importers of unlicensed medicines that Centrally Authorised medicines are the subject of Marketing Authorisations from the EMA, valid in all Member States and therefore cannot be notified for import into the UK as unlicensed medicines, unless …

Too much pressure: a behavioural approach to Data Integrity (Part 2)

Posted by: David Churchward, Posted on: 30 March 2017 - Categories: Compliance matters, Good clinical practice, Good distribution practice, Good laboratory practice, Good manufacturing practice, Good pharmacovigilance practice

The first post in this series described the importance of organisational behaviour on the success of data integrity control measures. Behavioural issues are often unsuitable for technical guidance, but the Inspectorate blog provides an opportunity to address this complex issue.