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

Publication
Article
Pharmaceutical TechnologyPharmaceutical Technology-03-02-2005
Volume 29
Issue 3

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.

External Link - article-150844.pdf

Articles in this issue
March 2005
Packaging Becomes Part of the Prescription
Appraisal of the Laser Diffraction Particle-Sizing Technique
Optimism Taking Over in Pharmaceutical Chemicals
In the Spotlight - March 2005
IPEC-Americas? Updated Significant Change Guide for Bulk Pharmaceutical Excipients
A “Disclosure Defense” in Liability Law
Managing Aseptic Interventions
Validating Automated Systems
Implications of Photostability on the Manufacturing, Packaging, Storage, and Testing of Formulated Pharmaceutical Products
Combination Products Raise Manufacturing Challenges
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