GOV.UK
Creating written procedures for new applicants for Wholesale Dealer Authorisations (WDA)
Are you a new applicant establishing a small wholesale dealers’ operation; and do you need guidance for creating written procedures?
Good distribution practice
Do wholesale distributors require pharmacovigilance agreements?
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
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
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.
PIC/S meeting - February 2017
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)
Global regulatory collaboration relating to data integrity remains a priority for MHRA and its international partners.
MHRA GDP Symposium 2016
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)
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
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.