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 (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 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 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

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