How to Interpret the Latest FDA Guidance on Manufacturing Establishment Information and its Relationship to IDMP Standards
Feb02

How to Interpret the Latest FDA Guidance on Manufacturing Establishment Information and its Relationship to IDMP Standards

The draft guidance on manufacturing establishment information coordinates all of the information about an establishment and its associated business operations into one structured format. The draft guidance states, “Electronic submissions of manufacturing establishment information (MEI) must include complete information on the locations of all manufacturing sites, including packaging and control sites, for both drug substance and drug product.”

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