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Blog

Visit us at Table 9 at PDA EU Annual Meeting

By John Henchion, June 22, 2018

 

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E-Pub: The Importance of Annex 1

By John Henchion, May 21, 2018

Annex 1 - "Manufacture of Sterile Medicinal Products." was first published in 1971. However, the first revision since then is currently in process. And this revision will have impact way beyond the EU borders.

World Health Organisation (WHO-all United Nations are members) and Pharmaceutical Inspection Co-operation Scheme (PICs) are actively involved in the update of Annex 1. The guidance is being developed with global harmonization of standards in mind.

Click below to view the full brochure on our understanding and capabilities surrounding the changes to come with this update:

Click Here to Read our E-Pub on our Understanding of Annex 1

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Implementing USP Visual Inspection Requirements

By Eamonn Vize, November 21, 2017

The word “visible” in the expression, Visual Inspection of Parenteral Products, has no meaning unless the viewing conditions are specified. 

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How to Understand ASTM E2500