Step/materials Test(s)/method(s) Acceptance criteria 2.3.S.2.5 Process Validation and/or Evaluation (name, manufacturer) Description of process validation and/or evaluation studies (e.g. for aseptic processing and sterilization): 2.3.S.2.6 Manufacturing Process Development (name, manufacturer) Description and discussion of the significant changes made to the manufacturing process and/or manufacturing site of the API used in producing comparative bioavailability or biowaiver, stability, scale-up, pilot and, if available, production scale batches: 2.3.S.3 Characterisation (name, manufacturer) 2.3.S.3.1 Elucidation of Structure and other Characteristics (name, manufacturer) List of studies performed (e.g. IR, UV, NMR, MS, elemental analysis) and conclusion from the studies (e.g. whether results support the proposed structure): Discussion on the potential for isomerism and identification of stereochemistry (e.g. geometric isomerism, number of chiral centres and configurations) of the API batch(es) used in comparative bioavailability or biowaiver studies: Summary of studies performed to identify potential polymorphic forms (including solvates): <including identification of and data on the API lot used in bioavailability studies> Summary of studies performed to identify the particle size distribution of the API: <including identification of and data on the API lot used in bioavailability studies> Other characteristics: 2.3.S.3.2 Impurities (name, manufacturer) Identification of potential and actual impurities arising from the synthesis, manufacture and/or degradation:
Step/materials Test(s)/method(s) Acceptance criteria 2.3.S.2.5 Process Validation and/or Evaluation (name, manufacturer) Description of process validation and/or evaluation studies (e.g. for aseptic processing and sterilization): 2.3.S.2.6 Manufacturing Process Development (name, manufacturer) Description and discussion of the significant changes made to the manufacturing process and/or manufacturing site of the API used in producing comparative bioavailability or biowaiver, stability, scale-up, pilot and, if available, production scale batches: 2.3.S.3 Characterisation (name, manufacturer) 2.3.S.3.1 Elucidation of Structure and other Characteristics (name, manufacturer) List of studies performed (e.g. IR, UV, NMR, MS, elemental analysis) and conclusion from the studies (e.g. whether results support the proposed structure): Discussion on the potential for isomerism and identification of stereochemistry (e.g. geometric isomerism, number of chiral centres and configurations) of the API batch(es) used in comparative bioavailability or biowaiver studies: Summary of studies performed to identify potential polymorphic forms (including solvates): <including identification of and data on the API lot used in bioavailability studies> Summary of studies performed to identify the particle size distribution of the API: <including identification of and data on the API lot used in bioavailability studies> Other characteristics: 2.3.S.3.2 Impurities (name, manufacturer) Identification of potential and actual impurities arising from the synthesis, manufacture and/or degradation:
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