ATMPRoadMap
  • ATMP Roadmap

    The ABPI (Association of British Pharmaceutical Industry) and AAC (Accelerated Access Collaborative) launched at the end of 2021 an ‘ATMP Roadmap’ that has been created on their behalf by Ernst & Young with input from organisations such as the Cell …Read More »
  • The Joint Professional Bodies Qualified Persons Eligibility Scheme News Bulletin

    The Joint Professional Bodies (JPB) are committed to keeping in touch with the Qualified Person’s community and will be updating this page with a quarterly newsletter to share relevant updates and information about the QP eligibility scheme. The bulletin published …Read More »
  • EXCiPACT’s Good Warehousing Practices (GWP)

    EXCiPACT has two core standards covering manufacturing operations (GMP) and repacking and relabeling activities (GDP). However, the excipient supply chain includes those who only transport and store the materials in a facility. For these organisations, the GDP standard is too …Read More »
  • July 2021 – Updates from WHO

    July 2021 had plenty of updates in the pharmaceutical space from the World Health Organization. As part of its weekly update for members and the general public, PQG provides a summary of these below.  Back in 2020, the WHO published …Read More »
  • MHRA’s webinar on protecting the security of the UK supply chain – 13 August 2021 – 10 AM UK time

    This MHRA webinar will raise awareness of the threat of stolen medicines being re-introduced into the regulated supply chain. The event will be delivered by GDP Inspectors with expert knowledge of the issue and the capability to offer practical advice …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 …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 …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 …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 »

ATMP Roadmap

The ABPI (Association of British Pharmaceutical Industry) and AAC (Accelerated Access Collaborative) launched at the end of 2021 an ‘ATMP Roadmap’ that has been created on their behalf by Ernst & Young with input from organisations such as the Cell and Gene Therapy Catapult, The Medicines and Healthcare products Regulatory Agency (MHRA), NHS England (NHSE)... Read more

The Joint Professional Bodies Qualified Persons Eligibility Scheme News Bulletin

The Joint Professional Bodies (JPB) are committed to keeping in touch with the Qualified Person’s community and will be updating this page with a quarterly newsletter to share relevant updates and information about the QP eligibility scheme.The bulletin published in December 2021 is available here.   The Joint Professional Bodies intend on hosting the next... Read more

EXCiPACT’s Good Warehousing Practices (GWP)

EXCiPACT has two core standards covering manufacturing operations (GMP) and repacking and relabeling activities (GDP). However, the excipient supply chain includes those who only transport and store the materials in a facility. For these organisations, the GDP standard is too detailed as it includes repacking operations where the excipient may be exposed to the environment.... Read more

July 2021 - Updates from WHO

July 2021 had plenty of updates in the pharmaceutical space from the World Health Organization. As part of its weekly update for members and the general public, PQG provides a summary of these below.  Back in 2020, the WHO published draft documents on ‘Good Manufacturing practices for medical gases’, ‘Good Manufacturing Practices for Investigational Products’... Read more

MHRA's webinar on protecting the security of the UK supply chain - 13 August 2021 - 10 AM UK time

This MHRA webinar will raise awareness of the threat of stolen medicines being re-introduced into the regulated supply chain. The event will be delivered by GDP Inspectors with expert knowledge of the issue and the capability to offer practical advice on steps the audience can take to protect themselves and patients from the threat and... Read more

©2004-2022 Pharmaceutical Quality Group. All rights reserved. | Copyright, Disclaimer and Privacy Policy

Web site design and development by Futuresys Ltd