A clear distinction between the release of a batch and its certification by the Qualified Person (QP), directions for what responsibilities the QP can share and how, and a template for use by a QP to sign off on a subset of manufacturing steps are among the significant changes EMA has incorporated into a revision of its Annex 16, which was released for public comment in early July.
The EMA is providing a four-month consultation period – one month longer than is typical – to factor in the European summer holiday period. Comments are due by November 5.
At a conference on the “Current and Emerging EU Regulations and Inspection Trends” co-sponsored by PDA and the Irish Medicines Board (IMB) in Dublin in July, IMB GMP Manager Paul Sexton provided insights on the changes to the annex and why they were put in place. Sexton has been participating in the revision effort, which is being shepherded by EMA’s Inspector’s Working Group.
Some of the key drivers for the revision, Sexton explained, include: ● the globalization of the pharmaceutical supply chain, which is “putting more distance between QPs and the manufacturing operations for which they are ultimately responsible” ● the introduction of new quality control strategies such as real-time release ● the implications of the falsified medicines directive (FMD) and the refining of the GDPs in Europe ● the principles embedded in ICH Q8-10 ● a new manufacturing and import authorization (MIA) interpretation document, and ● differences between member states in interpreting the existing Annex 16 .
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