3.2.S. Drug Substance |
3.2.S. Drug
Substance |
3.2.S.1. General information
|
· Nomenclature of the product.
· Information on the structural component and summary of the physical
and biological characteristics of the substance.
· General physicochemical properties of the active substance.
|
3.2.S.2. Manufacture
|
· List of manufacturers of the active substance.
· Summary of the manufacturing process (complete flowchart and reagents
used should be included).
· Controls of materials (e.g., raw materials, starting materials,
reagents)
· Controls of critical steps and intermediates of the active substance.
· Description of any development work done to optimise the production
operations.
|
3.2.S.3. Characterization
|
· Elucidation of structure and other characteristics.
· Impurities (process-related impurities and cellular impurities).
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3.2.S.4. Control of the drug substance
|
· Specifications (for the active substance release).
· Description of the analytical methods used for testing the active
substance.
· Suitability, qualification, or validation data of the analytical
methods used (depend on the status of the product development).
· Batch analysis (tables of all the manufactured data of the active
substance).
· Justification of specifications.
|
3.2.S.5. Reference Standards or Materials |
· Characterization of the
batch substance to establish a reference standard (only in case of
international standards available). |
3.2.S.6. Container Closure System |
· Information on the immediate
packing material. |
3.2.S.7. Stability |
· Data of storage conditions (in case it is not
immediately processed). |
3.2.P. Drug Product |
3.2.P. Drug
Product |
3.2.P.1. Description and composition |
· Qualitative and quantitative
composition of the finished medicinal product. |
3.2.P.2. Pharmaceutical development |
· Short description of the
formulation development and justification of using any new
pharmaceutical form or excipient. |
3.2.P.3. Manufacture
|
· List of manufacturers of the drug product.
· Description of the manufacturing process and controls.
· Control of all material used in the manufacture of the substance.
· Control of critical steps and intermediates.
· Process validation and/or evaluation.
· Manufacturing process development.
|
3.2.P.4. Control of excipients |
· References to the pharmacopoeia for
the excipient’s specifications. |
3.2.P.5. Control of the medicinal product
|
· Drug product specifications (quality attribute) for product release.
· Analytical procedures and validation of these analytical methods.
· Batch analysis (with data from all the manufactured drug products).
· Additional impurities observed in the medicinal product.
· Justification of the specifications (for product release).
|
3.2.P.6. Reference Standards or Materials |
· Parameters for
characterisation of reference standards (where
applicable). |
3.2.P.7. Container Closure System |
· Information on the immediate
packaging material. |
3.2.P.8. Stability |
· Stability studies of the medicinal
product. |