The annual metrics report for GCP referrals has been published by the MHRA. In 2019, the MHRA received a total of 112 serious breach notifications.
USPs Expert Committee for Botanical Dietary Supplements and Herbal Medicines proposes a new general chapter on Pyrrolizidine Alkaloids (PAs).
The WHO published the revised draft of its guideline "Good Manufacturing Practices: water for pharmaceutical use" already end of July. The first revised draft of the guideline was published in May 2020. The new, second version contains further changes.
The topics data integrity/audit trail generate a multitude of questions. Current questions are addressed in a loose sequence of News. Question 8: What is the procedure for devices with standard audit trail functions if only a fraction of the data is relevant for the audit trail review?
The FDA issued a new guideline entitled Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research. The draft guidance also introduces key FDA regulatory concepts to stakeholders who may be less familiar with the FDA and the FDAs authorities than other drug developers.
Quality Risk Management (QRM) is a fundamental requirement in the Good Distribution Practice (GDP) environment. It is applicable to a variety of activities and processes, such as temperature mapping studies, supplier qualification, deviations, and change control. In this context, a new post, entitled "A Practical example of applying Quality Risk Management in GDP - Transportation Risks", has been published in the MHRA Inspectorate blog.
The EU-GDP Guidelines require that wholesale distributors have to appoint a responsible person (RP) for GDP. A written job description of the responsible person should define their authority to take decisions with regard to their responsibilities. But what are the elements which should be covered in such a job description?
The EMA has updated the Q&As on their Good Clinical Practice (GCP) page. In particular, a new Q&A Nr. 13 clarifies the responsibilities of sponsors and investigators regarding data entered into the eCRF and PI oversight.
Sponsors of EU clinical trials, where the QP is currently located in the UK, need to establish an EU-QP by the end of the transition period. In addition the sponsor of a clinical trial or a legal representative must be established in the EU. Read more here.
The European Commission (EC) published an updated Version 2.4 of the Questions & Answers relating to the Clinical Trials Regulation.