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EU GMP Annex 1 Revisions Will Require Stronger Visual Inspection Programs

 
• By Joanne S. Eglovitch

An industry expert tells pharmaceutical manufacturers to be aware of changes proposed for Annex 1 of the European Commission's GMP guide that affect visual inspections and particulate control for new parenteral drugs. The revision calls for stricter standards for visually screening products for defects.

Eye looks through magnifying glass

Drug manufacturers should beef up visual inspection programs to comply with stricter standards for visually testing parenteral drugs for defects under proposed changes to Annex 1 of the European Commission's good manufacturing practice guidelines for medicinal products, an expert on visual inspections says.

The proposed revision clarifies the types of containers subject to visual testing and calls for the use of automated methods...

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