Compliance matters

Organisations:	Medicines and Healthcare products Regulatory Agency

An Inspector Calls: Part 1, GMP Short Notice and Unannounced Inspections

Tracy Moore, 26 June 2017 — Compliance matters, Good manufacturing practice

An update on the use of short notice and unannounced GMP inspections

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.

2016 GMP inspection deficiency data trend

Mark Birse, 21 April 2017 — Compliance matters, Good manufacturing practice

Earlier this week we published the 2016 GMP inspection deficiency data trend.

Computer System Validation - GCP

Balall Naeem, 20 April 2017 — Compliance matters, Good clinical practice

This post focuses on Computer System Validation (CSV) and is a combination of a case study seen at a single organisation and some of the common findings GCP Inspectors have seen across a number of recent inspections.

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.

Responsibilities of MAHs participating in work-sharing initiatives for additional risk minimisation measures

Kiernan Trevett, 21 March 2017 — Compliance matters, Good pharmacovigilance practice

Risk minimisation measures aim to optimise the safe and effective use of a medicinal product throughout its life cycle.

Prevention of cross contamination in shared facilities – Chapter 3 & 5 and the Guideline on Setting Health Based Exposure Limits

Graeme McKilligan, 15 March 2017 — Compliance matters, Good manufacturing practice

A revision to chapters 3&5 of the EU GMP Guide including modifications to the control of cross contamination sections came into effect on 1st March 2015.