DMF vs CEP
Two different regulatory instruments that solve a similar problem in different jurisdictions, and are not interchangeable.
A US Drug Master File and a European Certificate of Suitability both let a plant support your filing without disclosing its process to you. They are issued by different authorities, cover different scopes and are accepted in different markets.
This guide is in preparation and will set out which instrument applies where, and what to ask a supplier for when you are filing in more than one market.
Who issues what
FDA versus EDQM, and what each instrument actually certifies.
Market acceptance
Where each is accepted, and where neither is sufficient alone.
Filing in both
What to ask a supplier for when the product goes to both markets.
Related
Neck Finish Guide
How to read a neck finish callout and match a closure to a container.
Cap Liner Selection
Choosing a liner against fill temperature, pH and process.
API Sourcing Guide
Qualifying an API source, from sample to second-source approval.
Lead Time and Incoterms
Where the time actually goes, and who carries which risk.
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