Notary attested copy of all the relevant pages in PMF on viral 13. inactivation/purification processes adopted for the manufacture of Factor IX. Notary attested copy of all the relevant pages in PMF on viral 14. inactivation/purification processes adopted for the manufacture of FIEBA. Statement on the methods adopted for inactivation/purification in the 15. format as given in Annexure V. Notary attested copy of all relevant pages in PMF on viral detection tests 16. performed in the source plasma, during manufacturing process and in finished product for Factor VIII. Notary attested copy of all relevant pages in PMF on viral detection tests 17. performed in the source plasma, during manufacturing process and in finished product for Factor IX. Notary attested copy of all relevant pages in PMF on viral detection tests 18. performed in the source plasma, during manufacturing process and in finished product for FIEBA. 19. Statement on the detection tests in the format as given in Annexure VI. Documents to the purity of the offered product as defined by the WFH 20 for Factor VIII. Documents to prove the purity of the offered product as defined by the WFH 21. for Factor IX. Statement on purity of the offered product in the format as given in 22. Annexure VII. Notary attested copy of all the relevant pages on donor traceability in PMF 23. for Factor VIII. Notary attested copy of all the relevant pages on donor traceability in PMF 24. for Factor IX. Notary attested copy of all the relevant on donor traceability in PMF for 25. FIEBA. Details of batches tested in NIB since 2015-16 as in the format given in 26. Annexure VIII. Notary attested copy of reports of all the batches tested in NIB since 27. for Factor VIII. Notary attested copy of reports of all the batches tested in NIB since 28. for Factor IX. Notary attested copy of reports of all the batches tested in NIB since 29. for FIEBA. Statement of supply of Factor VIII made to the organizations listed in 30. Annexure IX. Statement of supply of Factor IX made to the organizations listed in 31. Annexure IX.
13. Notary attested copy of all the relevant pages in PMF on viral inactivation/purification processes adopted for the manufacture of Factor IX. 14. Notary attested copy of all the relevant pages in PMF on viral inactivation/purification processes adopted for the manufacture of FIEBA. 15. Statement on the methods adopted for inactivation/purification in the format as given in Annexure V. 16. Notary attested copy of all relevant pages in PMF on viral detection tests performed in the source plasma, during manufacturing process and in finished product for Factor VIII. 17. Notary attested copy of all relevant pages in PMF on viral detection tests performed in the source plasma, during manufacturing process and in finished product for Factor IX. 18. Notary attested copy of all relevant pages in PMF on viral detection tests performed in the source plasma, during manufacturing process and in finished product for FIEBA. 19. Statement on the detection tests in the format as given in Annexure VI. 20 Documents to the purity of the offered product as defined by the WFH for Factor VIII. 21. Documents to prove the purity of the offered product as defined by the WFH for Factor IX. 22. Statement on purity of the offered product in the format as given in Annexure VII. 23. Notary attested copy of all the relevant pages on donor traceability in PMF for Factor VIII. 24. Notary attested copy of all the relevant pages on donor traceability in PMF for Factor IX. 25. Notary attested copy of all the relevant on donor traceability in PMF for FIEBA. 26. Details of batches tested in NIB since 2015-16 as in the format given in Annexure VIII. 27. Notary attested copy of reports of all the batches tested in NIB since for Factor VIII. 28. Notary attested copy of reports of all the batches tested in NIB since for Factor IX. 29. Notary attested copy of reports of all the batches tested in NIB since for FIEBA. 30. Statement of supply of Factor VIII made to the organizations listed in Annexure IX. 31. Statement of supply of Factor IX made to the organizations listed in Annexure IX.
Annexures%20HAEM.docx