Information about Active Pharmaceutical Ingredient (API)

Information about Active Pharmaceutical Ingredient (API) which should be included in registration dossier for registration in Russia:

Copy of Document containing the following information about Active Pharmaceutical Ingredient (API) or few API’s, used for manufacturing of Finished Drug Product:

1. Name, structure, common properties.
2. Name and adress of manufacturer.
3. Manufacturing Technology with description of manufacturing steps and methods of control for all manufacturing steps.
4.  Description of development of manufacturing process.
5. Description of contorol of critical steps of manufacturing and intermediates.
6. Process validation.
7. Properties and structure of active ingredients.
8. Impurity characterization.
9. Specification and justification of specification.
10. Analitycal procedures.
11. Validation of analytical procedures.
12. Batch analysis.
13. List of Standards and reagents used for quality control.
14. Description of characteristics and properties of packaging materials.
15. Stability data of API.
16. Shelf-life.