ASSESSMENT POLICY
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).
CTD Section
Applicant's part
Restricted part
General Information
Nomenclature
X
Structure
X
General Properties
X
Manufacture
Manufacturer(s)
X
Description of Manufacturing Process and Process Controls
(a)
(b)
Control of Materials
X
Controls of Critical Steps and Intermediates
(c)
(d)
Process Validation
(e)
X
Manufacturing Process Development
X
Characterization
Elucidation of Structure and other Characteristics
X
Impurities
X
(f)
Control of Drug Substance
Specification
X
Analytical Procedures
X
Validation of Analytical Procedures
X
Batch Analyses
X
Justification of Specification
X
(g)
Reference Standards or Materials
X
Container Closure System
X
Stability
Stability Summary and Conclusions
X
Post-approval Stability Protocol and Stability Commitment
X
Stability Data
X
(a) The applicant's part should contain, at least, the synthetic scheme and simplified description of the manufacturing process, from the introduction of the starting material.
(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.
(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.
