The Pharmaceutical Quality Group

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 »
New monograph: GDP for Active Substances
July 7, 2020
If medicinal products are to be of the quality consumers and regulators expect, then the active substances within them need to be manufactured in accordance with Good Manufacturing Practice and their quality and integrity maintained throughout the supply chain through …Read More »
Extension to deadline for Nitrosamines risk assessments
March 26, 2020
A number of recalls have occurred in the last two years following the finding of nitrosamine impurities in medicinal products, firstly the ‘sartans’ and then other products, notably ranitidine. This has led to enhanced regulatory agency and pharmaceutical industry action to …Read More »
MHRA Covid-19 collection and GxP inspections news release UPDATED
March 22, 2020
The MHRA have created a collection on their website for information related to Covid-19. Of particular interest to members will be information about clinical trials and MHRA services. The collection may be found here. Separately, MHRA have issued a news …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
							
EU Exit - Acting as a RPi - Responsible Person (import) from 1 January 2021
				Dan Paul Andreianu
			
				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 September 2020 describes how you can apply to be a RPi, and how to verify...
									Read more
							
IPEC Position Paper on Excipients GMP standards and guides
				Philip Butson
			
				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 will be helpful to those involved in both the manufacture of pharmaceutical excipients and the...
									Read more
							
EXCiPACT 2Q 2020 Board Report now available
				Philip Butson
			
				PQG has received the 2Q 2020 Board Report from EXCiPACT and this may be read here
									Read more
							
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