The asssessment policy defines the criteria for the quality assesment of active pharmaceutical ingredient dossier (DIFA), considering RDC 359/2020 and ICH Guidelines. The content is organized according to the quality module of the active pharmaceutical ingredient (3.2.S) - CTD (ICH M4Q).
(b) The restricted part should contain all information regarding the manufacturing process.
(c) Information that is also relevant for the marketing authorization holder.
(d) Information that is related to the detailed description of the manufacturing process and that is not relevant for the marketing authorization holder.
(e) For sterile APIs, when there is no subsequent sterilization step in the manufacture of the drug product.
(f) Information about potential impurities that pertain to the sequential procedural narrative can be included in the restricted part, provided that there is unequivocal evidence that the impurity does not need to be controlled in the API.
(g) Information related the the sequential procedural narrative, control of materials and process validation can be included in the restricted part.