Regulatory Affairs

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Pharmaceutical professionals at all stages of their careers turn to ISPE for the latest regulatory information and for the opportunity to provide input on the policies and regulations that ensure the world’s safe medicines.

A Comparison of Process Validation Standards

  • This article in the current issue of Pharmaceutical Engineering presents a comparison between the Global Harmonization Task Force (GHTF) validation standard and the US Food and Drug Administration’s (FDA’s) process validation guidance.
    Download Article ( 384 KB)

Regulatory Comments

ISPE invites its Members to comment on proposed regulations and guidance that affect the bio/pharmaceutical industry.


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Last Update: 18 February 2014

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