List of Documents required for preparation of China DMF

1. Administrative Office and Manufacturing Facility Addresses.

2. Manufacturing Process Flow Chart & Reaction Scheme.
3. Manufacturing Process in brief (Write up).
4. Specifications, Method of Analysis and COA of Finished Product. (Three current
Batches) along with the Supportive Raw Data and Chromatograms.
5. Packaging Process Details. (Primary and Secondary Packing).
6. Details of the Working / Reference Standard. (COA, Validity, Date of Preparation,
SOP for Preparation, IR, UV, HPLC).
7. GMP Certification / ISO Certification, etc (if any).
8. 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.
9. Stability Studies Protocol and Report with Real Time & Accelerated Stability Data
along with supportive Analytical Reports & Chromatograms. (It should be minimum
for 6 months).
10. Microbial Testing (if any applicable) reports.
11. Structural Elucidation Studies (Elemental Analysis, IR, NMR C & H, Mass, UV,
XRD, DSC, etc). IR & UV of WS.
12. Specification, MOA & COA of the Packaging Material used.
13. Forced Degradation Studies (Protocol and Report).
14. International Audit report and CAPA for the same.
15. Carry over / Unidentified Impurities; Identification and analysis of the same
(Potential / Catalyst / Inorganic / Solvent Traces)
16. Detailed study on Isomerism / Polymorphism / etc (If applicable)