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Quality for listed medicines

Formerly included in ARGCM V8.0 Part B
20 May 2020
Download Quality for listed medicines

Description

Provides guidance for sponsors on the information required to establish quality for listed medicines:

  • Scientific guidelines on quality
  • Finished product specifications and certificates of analysis
  • Certificate of analysis for finished products
  • 'Quantified by input' for listed medicines
  • Requirements for specific ingredients

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