The MHRA published an updated Guidance on manufacturing, importing, distributing and supplying of cannabis-based products for medicinal use. Amongst others, the MHRA will require a valid GMP certificate for the site of manufacture.
The Qualified Person (QP) often reviews the batch documentation personally prior to certification of a batch. But is the QP obliged to review the batch documentation?
It is official now: the EU Commission has confirmed the full functionality of the Clinical Trials Information System in the Official Journal of the EU. This means that the Clinical Trials Regulation 536/2014 (CTR) will become applicable on 31 January 2022. What are the GMP / GCP changes associated with this?
Are you familiar with a "non-paper"? This is the name given by the EU Commission to a new document that describes proposed solutions for the practical handling of problems within the framework of the Northern Ireland Protocol.
In January 2020, EMA published a draft of a so-called reflection paper entitled "Good Manufacturing Practice and the Marketing Authorisation Holder". Now the final document has been published.
Last year the WHO published draft documents on "Good manufacturing practices for investigational products" and "Good practices for research and development facilities". After consolidation of comments received and review of feedback, revised versions of the two guidelines have now been published for a second round of public consultation. Read more about WHO´s revised guideline on GMP for IMPs.
The EMA has published two draft guidelines on the quality requirements for IMPs (small and large molecules). According to the Agency, the documents are to be seen in connection with the Clinical Trials Regulation (EU) No. 536/2014 which is expected to become applicable in January 2022.
Last year the WHO published draft documents on "Good manufacturing practices for investigational products" and "Good practices for research and development facilities". After consolidation of comments received and review of feedback, revised versions of the two guidelines have now been published for a second round of public consultation. Read more about WHO´s revised guideline on GxP for Development.
