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An Inspector Calls: Part 1, GMP Short Notice and Unannounced Inspections
An Inspector Calls: Part 1, GMP Short Notice and Unannounced Inspections
An update on the use of short notice and unannounced GMP inspections
Use of Freezers
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.
MHRA Inspectorate Organogram
We have today updated the sidebar of the MHRA Inspectorate Blog to provide access to the MHRA Inspectorate organogram.
2016 GMP inspection deficiency data trend
Earlier this week we published the 2016 GMP inspection deficiency data trend.
The pre-election period
In the coming weeks, you will notice that it’s much quieter than usual on the MHRA Inspectorate blog. It’s because between midnight on Friday, 21 April and the general election on 8 June is the pre-election period.
Computer System Validation - GCP
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.
Losing GSi – MHRA emails are changing
From 10 April, we are removing .gsi from our email addresses. Technology has changed a lot since the introduction of the Government Secure Intranet (GSi) in 1996
Imported Unlicensed Medicines and Centrally Authorised Medicines intended for other EU Member States
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)
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
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
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.