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How the new draft of Annex 1, Manufacture of Sterile Medicinal Products impacts environmental monitoring programmes

Posted: 12 September 2018 | , | No comments yet

This article explores how the new draft of Annex 1, Manufacture of Sterile Medicinal Products impacts environmental monitoring programmes.

The new draft1 of Annex 1, Manufacture of Sterile Medicinal Products, was published on 20th December 2017, setting a milestone for adjustments needed within European agencies overseeing drug product regulatory applications. During the revision process, the US Food and Drug Administration (FDA) and the Pharmaceutical Inspection Convention and Pharmaceutical Co-Operation Inspection Scheme (PIC / S) worked alongside the EU, demonstrating the critical need for standardised regulations reflecting the current state of sterile pharmaceutical manufacturing on a global scale.

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