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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
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.
Exports and customs procedures
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
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 …
Around the world in 80 ways (part 1 of 2)
The supply chain for Active Pharmaceutical Ingredients (APIs) has been increasing in complexity for a number of years with the potential for a number of players to be involved, with multiple possible routes around the world available (significantly more than …
2016 GMP symposium
It was a case of “lights, camera, action!” for the GMP days of the 2016 MHRA Symposium, with speakers making use of video clips, music, and pictures in order to deliver key messages.
Reference Safety Information II
Hello and welcome to Reference Safety Information II. Hopefully you will all have read my first Reference Safety Information (RSI) post which focused on how the RSI should be Identifiable, Approved and Consistent.