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.
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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