Articles by Irwin Silverstein, PhD - Pharmaceutical Technology

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Articles by Irwin Silverstein, PhD

IPEC-Americas? Updated Significant Change Guide for Bulk Pharmaceutical Excipients

Mar 2, 2005

IPEC-Americas has just completed a major update to its significant change guideline to address current issues in the manufacture of excipient ingredients and to assist manufacturers in developing an impurity profile.

Excipient GMP Quality Standards: One is Enough

Jun 1, 2002

A new set of proposed GMP standards for excipents may present more problems than benefits.

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Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
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