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Asking the right questions when regulations are revised in sterile manufacturing

In this article, John Johnson, vice president, Pharma Biotech, NSF International, looks at the revision to Annex 1 and the important questions steriles manufacturers and pharma suppliers should be asking themselves.

By John Johnson
Asking the right questions when regulations are revised in sterile manufacturing
Published: | 2 min read
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In this article, John Johnson, vice president, Pharma Biotech, NSF International, looks at the revision to Annex 1 and the important questions steriles manufacturers and pharma suppliers should be asking themselves.

questions

Regardless of the dosage form you supply, whenever the EudraLex Volume IV GMP regulations are revised, it is important to take in the wider picture. With the introduction of a significant revision to Annex 1: Manufacture of Sterile Medicinal Products, licence holders and pharma suppliers should ask themselves:

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