MHRA released a Q&A on the application of Annex 16 to investigational medicinal products (IMPs). In May 2016, MHRA posted ‘Manufacture of Investigational Medicinal Products – Frequently Asked Questions’, and earlier this year posted the first part of ‘Annex 16 QP Certification and Batch Release – FAQs’. Topics include: • the requirements for sampling and testing of imports • the legal duties of the IMP QP • audit reports of contract manufacturing/packaging/testing sites • supply chain maps • document retention times • the handling of unexpected deviations, and • shipping IMPs to a clinical site under quarantine.
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