Category Archives: Latest Pharmaceutical News

PQG and GDPR

With the implementation of the new General Data Protection Regulation, PQG has produced a Notice on Personal Data Processing which may be found HERE

New GDP monograph now available!

Arising from the PQG’s 2013 – 2016 collaboration with ECA that created a series of chapter guides based on the 2013 EU GDP Guidelines, a new printed monograph on Good Distribution Practice is now available to purchase from the PQG …

Presentations from MHRA meeting now available

The presentations from the 21st annual meeting with MHRA held on 20-Mar-2018 are now available in the members only area of the website here. Ian Jackson is still working to finalise the written answers to submitted questions and these will …

Revised EU GMP Guidelines for IMPs

The EU have published revised GMP guidelines for investigational medicinal products which will come into effect on the application date of the Clinical Trial Regulation (536/2014), which is currently expected to be 2H2019.¬† The document is in EudraLex Volume 10 …

New EU GMP Guideline for ATMPs

22-Nov-2017: The European Commission has today published a new Guideline on Good Manufacturing Practice for Advanced Therapy Medicinal Products¬†as a new Part IV of EudraLex Volume 4. https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/2017_11_22_guidelines_gmp_for_atmps.pdf ATMP manufacturers should comply with these Guidelines no later than 22 May …

IPEC-Europe infographic on excipients

IPEC Europe have created an interesting infographic on pharmaceutical excipients which may be accessed here

NEW IPEC-PQG Excipients GMP guide

A revised version of the IPEC-PQG JOINT GOOD MANUFACTURING PRACTICE GUIDE FOR EXCIPIENTS has just been published and is available for free download from the PQG Shop (log in as a PQG member here first, then use the menu on …

NEW PS 9000:2016 GMP Pharmaceutical Packaging Materials Standard NOW AVAILABLE

Following a successful launch event on 14th July, the Pharmaceutical Quality Group is pleased to announce the new version of PS 9000 is now available from the PQG shop. With a foreword by Mark Birse of the MHRA, this updated …