The Pharmaceutical Quality Group

MHRA – End of Transition Period – Week 43 Updates
October 23, 2020
The MHRA has published further guidance in relation to supplying medicines and medical devices after the end of the transition period. On medicines we have the following updates: Sourcing medicines for the Great Britain market from an approved country for …Read More »
GDP Requirements and the ECA/PQG Good Distribution Practice monographs
October 20, 2020
GDP monographs will be the main topic of the webinar presented by Phil Butson (PQG) on Tuesday, 27 October. The live webinar (GDP Requirements and the ECA/PQG Good Distribution Practice monographs) will be held on behalf of Pharmaceutical Quality Group …Read More »
Trainee QP CPD – Virtual Event
September 30, 2020
PQG’s second Trainee QP CPD – Virtual Event will be held on the 20th October 2020. To facilitate the interactive nature of this meeting the number of delegates will be restricted to 30. More details and bookings here. David Moulding …Read More »
Data Integrity Webinar
September 24, 2020
On Tuesday 22 September 2020 PQG organised a Data Integrity Webinar with Dale Carter, Head of Quality – Evonik Corporation. In this presentation, Dale reviewed the recently released position paper on Data Integrity for Pharmaceutical Grade Excipients published by the International Pharmaceutical Excipients …Read More »
Week 36 – News
September 4, 2020
Just in case you missed some of this week’s news, here are the highlights: MHRA published on 1 September 2020 guidance for industry and organisations to follow after the end of the transition period. From 1 January 2021, the Medicines and …Read More »
EU Exit – Acting as a RPi – Responsible Person (import) from 1 January 2021
September 3, 2020
From 1 January 2021, a wholesale dealer in Great Britain may only import Qualified Person (QP) certified medicines from the European Economic Area (EEA) if certain checks are made by the ‘Responsible Person (import) (RPi)’. The guidance published on 1 …Read More »
IPEC Position Paper on Excipients GMP standards and guides
July 22, 2020
IPEC have issued a position paper outlining the content and purpose of three documents* addressing GMP requirements for excipients and the role that each can play in the implementation of appropriate GMP in the QMS of an excipient manufacturer. This …Read More »
EXCiPACT 2Q 2020 Board Report now available
July 22, 2020
PQG has received the 2Q 2020 Board Report from EXCiPACT and this may be read hereRead More »
Meeting report: Trainee QP, Sponsors and QP CPD meeting, 30-Jun-2020
July 21, 2020
Our very first virtual event was held on 30th June, dedicated to our QPs, Trainee QP and Sponsors. The event was held using the “WebEx Training” platform and limited to 30 attendees. The attendees varied in background and experience, from …Read More »

					
MHRA - End of Transition Period - Week 43 Updates
				Dan Paul Andreianu
			
				The MHRA has published further guidance in relation to supplying medicines and medical devices after the end of the transition period. On medicines we have the following updates: Sourcing medicines for the Great Britain market from an approved country for import or Northern Ireland from 1 January 2021 Importing investigational medicinal products into Great Britain...
									Read more
							
GDP Requirements and the ECA/PQG Good Distribution Practice monographs
				Dan Paul Andreianu
			
				GDP monographs will be the main topic of the webinar presented by Phil Butson (PQG) on Tuesday, 27 October. The live webinar (GDP Requirements and the ECA/PQG Good Distribution Practice monographs) will be held on behalf of Pharmaceutical Quality Group as part of MP’s Digital Week. During the Digital Week, Making Pharmaceuticals brings you a...
									Read more
							
Trainee QP CPD - Virtual Event
				Dan Paul Andreianu
			
				PQG’s second Trainee QP CPD – Virtual Event will be held on the 20th October 2020. To facilitate the interactive nature of this meeting the number of delegates will be restricted to 30. More details and bookings here. David Moulding (Registration Standards Specialist, RSC) will give a presentation on Applying for QP Eligibility. In the...
									Read more
							
Data Integrity Webinar
				Dan Paul Andreianu
			
				On Tuesday 22 September 2020 PQG organised a Data Integrity Webinar with Dale Carter, Head of Quality – Evonik Corporation.  In this presentation, Dale reviewed the recently released position paper on Data Integrity for Pharmaceutical Grade Excipients published by the International Pharmaceutical Excipients Council Federation (IPEC). The paper was developed to supplement published Regulatory guidance defining Data Integrity requirements...
									Read more
							
Week 36 - News
				Dan Paul Andreianu
			
				Just in case you missed some of this week’s news, here are the highlights: MHRA published on 1 September 2020 guidance for industry and organisations to follow after the end of the transition period. From 1 January 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) will be the UK’s standalone medicines and medical devices regulator....
									Read more
							
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