What are the requirements for the production process text and flow diagram of formula food for special medical purpose (FSMP)?
The production process text should describe the commercial production process of product in detail, including process flow, process parameters, critical control points. The related contents should be consistent with the production process R&D result, process verification, and commercial actual production process.
The production process flow diagram should be consistent with the related contents of production process text, and should include the main production process steps, main process parameters, cleanliness level of each link, and critical control points.
Source: SAMR
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