EU DMF

01. Rabeprazole Sodium IH (Sterile Bulk)

02. Esomeprazole Sodium IH (Sterile)

03. Aciclovir Sodium IH (Sterile)

04. Piperecillin+Tazobactum Sodium for Inj. IH (Sterile)

05. Clolstimethate Sodium USP (Sterile)

 List of Documents required for preparation of US DMF

1. Administrative Office and Manufacturing Facility Addresses.

2. Organogram of the Company.
3. Manufacturing Process Flow Chart & Reaction Scheme.
4. Manufacturing Process in brief (Write up).
5. Specifications, Method of Analysis and COA of Finished Product. (Three current
Batches) along with the Supportive Raw Data and Chromatograms.
6. Packaging Process Details. (Primary and Secondary Packing).
7. Details of the Working / Reference Standard. (COA, Validity, Date of Preparation,
SOP for Preparation, IR, UV, HPLC).
8. Site Master File.
9. Details of Vendor (Name, Address, Tel, E–mail & Contact person) for Key Raw
Materials.
10. GMP Certification / ISO Certification, etc (if any).
11. Determination of Impurities (Potential & Solvent) in Finished product, with all the
reports supported by Chromatograms also the validation Protocol and Report of
Method used for the determination of Impurities (Potential & Solvent). As well
Assay Method validation Protocol and Report of Method used, with supportive
Chromatograms.
12. Stability Studies Protocol and Report with Real Time & Accelerated Stability Data
along with supportive Analytical Reports & Chromatograms. (It should be minimum
for 6 months).
13. Microbial Testing (if any applicable) reports.
14. Structural Elucidation Studies (Elemental Analysis, IR, NMR C & H, Mass, UV,
XRD, DSC, etc). IR & UV of WS.
15. Complete BMR / Batch processing record for any 1 batch and Process Validation
Protocol and Report.
16. Specification, MOA & COA of all the Raw Materials used along with the COA of
the Suppliers and declaration on Solvents used by suppliers.
17. Specification, MOA & COA of the Packaging Material used. Drawing of the
Canister, MOC declaration and COA of the Packaging Material by supplier.
18. Open part DMF of the Starting material.
19. Forced Degradation Studies (Protocol and Report).
20. International Audit report and CAPA for the same.
21. Carry over / Unidentified Impurities; Identification and analysis of the same
(Potential / Catalyst / Inorganic / Solvent Traces)
22. Detailed study on Isomerism / Polymorphism / etc (If applicable)
23. A detailed manufacturing process development report.
24. Specific Identification / mention of Critical Process Parameters and Justification for
the same.