Good distribution practice

Organisations:	Medicines and Healthcare products Regulatory Agency

Use of Freezers

Terry Madigan, 20 June 2017 — 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

Mark Birse, 30 March 2017 — 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)

David Churchward, 30 March 2017 — 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.

PIC/S meeting - February 2017

Mark Birse, 13 March 2017 — Compliance matters, Good clinical practice, Good distribution practice, Good laboratory practice, Good manufacturing practice, Good pharmacovigilance practice

From 8 to 10 February 2017, the PIC/S Committee and PIC/S Executive Bureau meetings took place in Geneva, Switzerland

Too much pressure: a behavioural approach to Data Integrity (Part 1)

David Churchward, 10 March 2017 — Compliance matters, Good clinical practice, Good distribution practice, Good laboratory practice, Good manufacturing practice, Good pharmacovigilance practice

Global regulatory collaboration relating to data integrity remains a priority for MHRA and its international partners.

MHRA GDP Symposium 2016

Bernadette Wilson, 3 March 2017 — Compliance matters, Events and symposia, Good distribution practice

I am Bernadette Wilson a GDP Inspector who assisted with the organisation of the MHRA GMDP 2016 Symposium. I took to the stage for the first time this year to present on the topic of whistleblowing. I am pleased to …

Around the world in 80 ways (part 2 of 2)

Ewan Norton, 27 February 2017 — Compliance matters, Good distribution practice, Good manufacturing practice

Earlier this year I posted the first part of 'Around the world in 80 ways' focussing on API supply chains. Here as promised is part 2.

Annex 16 QP certification and batch release – frequently asked questions – part 1

Trevor Watson, 23 February 2017 — Compliance matters, Good distribution practice, Good manufacturing practice

In this post you’ll find the first in a series of ‘frequently asked questions’ related to the updated EU GMP Annex 16 on QP Certification and Batch Release.

Exports and customs procedures

Cheryl Blake, 14 February 2017 — Compliance matters, Events and symposia, Good distribution practice, Good manufacturing practice

Those of you who attended our symposiums in either Glasgow or London during December 2016 will have heard Jane Sewell – International Trade Development Liaison Officer from HMRC speak about the Unified Customs Code.

Overview of compliance management escalation processes used by the GMP Inspectorate

Alan Moon, 6 February 2017 — Compliance matters, Events and symposia, Good distribution practice, Good manufacturing practice, Inside the Inspectorate

At the GMDP Symposium 2016, Andrew Hopkins and I gave a presentation about the Inspection Action Group (IAG) and Compliance Management Team (CMT), to highlight the systems and processes in place for when compliance issues are identified at manufacturing and …