What is the difference between RSF and DMF?
The advantage of RSF is that it gives first hand information to the user. DMF (Drug Master File) is used by vendors in order to protect trade secrets and its content is only revealed to the FDA reviewers. RSF can be used world wide, DMF for other product than active ingredient (e.g. chromatography medium) is only applicable in the US. While DMF contains manufacturing information, RSF provides a list of raw materials but no description of the manufacturing process. Neither DMF nor RSF is subject to any authority approval. The contents are only reviewed in connection with a specific product application.
