• July 2021 – Updates from PIC/S

    July 2021 – Updates from PIC/S

    July has been a busy month with plenty of updates from PIC/S. At the beginning of July 2021, PIC/S published the guidance on ‘Good Practices for Data Management and Integrity in regulated GMP/GDP environments’ (PI 041-1) following three drafts, the …Read More »
  • Manufacturing of ATMP starting materials – is GMP required?

    Manufacturing of ATMP starting materials – is GMP required?

    On 23 Apr 2021, EMA published an important addition to their GMDP Q&A with the publication of ‘Questions and answers on the principles of GMP for the manufacturing of starting materials of biological origin used to transfer genetic material for …Read More »
  • Hot Topics Meeting with the MHRA and Industry Experts

    Hot Topics Meeting with the MHRA and Industry Experts

    Hot Topics Meeting with the MHRA and Industry Experts – 16th March 2021. The presentations shown at this meeting are available from the ‘Members Only’ area. Please remember to login to access. Questions received from attendees have been submitted, and …Read More »
  • MHRA – End of Transition Period – Week 43 Updates

    MHRA – End of Transition Period – Week 43 Updates

    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

    GDP Requirements and the ECA/PQG Good Distribution Practice monographs

    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 24/02/2021

    Trainee QP CPD – Virtual Event 24/02/2021

    The presentations from the Trainee QP, Sponsors and QP CPD Virtual Event  held on the 24th February 2021 are available in the ‘Members Only Area’. Please remember to login to access.Read More »
  • Data Integrity Webinar

    Data Integrity Webinar

    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

    Week 36 – News

    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

    EU Exit – Acting as a RPi – Responsible Person (import) from 1 January 2021

    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 »

July 2021 - Updates from PIC/S

July has been a busy month with plenty of updates from PIC/S. At the beginning of July 2021, PIC/S published the guidance on ‘Good Practices for Data Management and Integrity in regulated GMP/GDP environments’ (PI 041-1) following three drafts, the last being in November 2018. It is understood that at the same time two aide... Read more

Manufacturing of ATMP starting materials - is GMP required?

On 23 Apr 2021, EMA published an important addition to their GMDP Q&A with the publication of ‘Questions and answers on the principles of GMP for the manufacturing of starting materials of biological origin used to transfer genetic material for the manufacturing of ATMPs’. The document highlights that, whilst GMP certificates are not required for... Read more

Hot Topics Meeting with the MHRA and Industry Experts

Hot Topics Meeting with the MHRA and Industry Experts – 16th March 2021. The presentations shown at this meeting are available from the ‘Members Only’ area. Please remember to login to access. Questions received from attendees have been submitted, and answers will be posted as soon as available.   Read more

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