EC Draft Revision to Annex 1 “Manufacture of Sterile Medicinal Products”


The European Commission released a draft revision to Annex 1 “ Manufacture of Sterile Medicinal Products” on December 20, 2017.  The revisions have several major changes that will impact your sterile products and drug substance manufacturing.  This revision introduces Quality Risk Management for use with new technologies and processes and includes updates to the recommendations on clean rooms, sealing technologies and single-use systems. It also includes a new section on “Utilities” covering water, sterilization, filtration and cooling systems used for production of sterile products.  The draft is available for public comment until March 20, 2018.

Download the complete draft here.

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