The Pharmaceutical Quality Group

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 »
Making Pharmaceuticals postponed
March 22, 2020
With the ongoing Covid-19 situation, the organisers of Making Pharmaceuticals have reluctantly decided not to go ahead with the rearranged dates of 26/27 October 2020, but will now not hold a physical event at the Ricoh Arena until July 2021. However, …Read More »
Q&A from MHRA meeting now available
February 2, 2020
The initial set of written answers to the questions posed at the PQG annual meeting with MHRA in 2019 are now available in the members’ area. The remaining answers will be provided by MHRA as soon as possible.Read More »
Do you want to expand your experience?
February 18, 2014
Have you ever realised that working within PQG in one of its Monograph groups actually brings you into contact with more experienced PQG Members and allows you to add another line to your CV. We have several projects running at present …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
							
Meeting report: Trainee QP, Sponsors and QP CPD meeting, 30-Jun-2020
				Philip Butson
			
				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 those who are training to become a QP to others who had decades of experience...
									Read more
							
New monograph: GDP for Active Substances
				Philip Butson
			
				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 the application of Good Distribution Practice (GDP). In Europe, the Falsified Medicines Directive (2011/62/EU) amended...
									Read more
							
Extension to deadline for Nitrosamines risk assessments
				Philip Butson
			
				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 assess and manage the risks.  In Europe, a key element of this was the issue...
									Read more
							
		Follow the PQG LinkedIn Group
	
Tweets by PQGComm