Information about Finished Drug Product (FDP)

Document containing the following information about Finished Drug Product:

  1. Description and composition of Drug.
  2. Description of Pharmaceutical development (justification of composition, primary packaging and other).
  3. Manufacturing technology with description of stages and methods of quality control for each manufacturing step.
  4. Description of control of critical steps of manufacturing process and intermediates.
  5. Name, address of each manufacturing site involved in manufacturing process.
  6. Pharmaceutical compatibility.
  7. Microbiological characteristics.
  8. Batch size for batch of FDP
  9. Description of characteristics and properties of packaging materials.
  10. Validation and evaluation of manufacturing process.
  11. Requirement to quality of excipients (CoA, specification and justification).
  12. Analytical Procedures which is used for quality control of excipients.
  13. Validation of analytical procedures used for QC of excipients
  14. Information about usage of excipients human or animal origin.
  15. Information about novel excipients
  16. Requirement to quality of FDP (CoA, specification and justification).
  17. Analytical procedures for FDP
  18. Validation of analytical procedures used for QC of FDP.
  19. Batch analysis
  20. Characteriaztion of impurities.
  21. List of standards used for QC of FDP.
  22. Stability data for FDP.