Applicant		Chemical Name
Manufacturer
Classification	□ Drug substances of new chemical entity □ Drug substances of Annex 1

1. Origin, finding and developmental history	□ Origin, finding and developmental history ( Y / N / NE )
2. Data on structure elucidation	□ Structural Elucidation [ Mass, NMR, IR, UV, Elemental Analysis ] ※ Underline what you submit Others :
	□ Absolute stereostructure in case of optical isomer etc ( Y / N / NA / NE )
3. Data on Physico-chemical properties	□ Patent ( Y / N )
	□ Appearance : Color, Shape, Smell, Taste ( Y / N / NA / NE )
	□ Solubility : Water, Ethanol, Ether, Effects according to pH ( Y / N / NE )
	□ Hygroscopicity, pH, Dissociation constant ( Y / N / NA / NE )
	□ Melting point, Thermal analysis ( Y / N / NA / NE )
	□ Partition coefficient, Partition ratio ( Y / N / NA / NE )
	□ Polarity ( Y / N / NA / NE )
	□ Polymorphism ( Y / N / NA / NE )
	□ The ratio of isomers ( Y / N / NA / NE )
	□ The others ( Y / N / NA / NE )
	□ Summary of Related compounds ( Y / N / NE )
4. Data on stability	□ Data on Lot used for stability test ( manufacturing date, Lot number, Lot scale, Packaging and Containers ) ( Y / N / NE ) ※ Underline what you submit
	□ Long term stability testing ( Y / N ) □ Stress testing ( Y ( Temperature , Humidity , Light ) / N ) □ Accelerated testing ( Y / N )
	□ Summary of test result ( Y / N / NE ) □ Raw data of test result ( Y / N / NE ) □ Specifications and Test Methods ( Y / N / NE ) □ Signature of the study director and Summary of test result ( Y / N / NE )
	□ Storage conditions and Verification of storage period ( Y / N / NE )
5. Data on the manufacturing processes, packaging, containers, cautions in handling, etc.	□ Manufacturing processes ( The overall manufacturing process flow, Flow Chart of manufacturing route, Reaction scheme of the synthesis ) ( Y / N / NE )
	□ Data on specification of the starting materials, solvents, reagents, etc. used in each manufacturing process ( Y / N / NE )
	□ Data on amount of the starting materials, solvents, reagents, etc. used in each manufacturing process and yield ( Y / N / NE )
	□ In-process controls by each manufacturing step ( Y / N / NA )
	□ Detailed descriptions of key intermediates and information on their specifications and test methods ( Y / N / NA )
	□ Data on Container Closure System ( Y / N / NE ) ※ Certificate of analysis of primary packaging and containers should be included.
	□ Cautions in Handling ( Storage and Shipment including light, temperature, impact, etc. ) ( Y / N / NA )
6. Data on batch analysis for drug substances, analytical procedures, solvents used, etc.	□ Method of Approved API or Product ( Y / N )
	□ Data on Lot used for test ( Manufacturing date, Lot number, Lot size ) ( Y / N / NE ) ※ Underline what you submit
	□ Certificate of analysis of the three or more consecutive Lots ( Y / N ) □ Raw data of Certificate of analysis ( Y / N / NE )
	□ Description of analytical procedures ( Y / N ) □ In house specification ( Assay, Impurity, Residual Solvents ) ( Y / N ) ※ Underline corresponding data ※ Validation data should be attached for any analytical methods which are not described in official compendia.
	□ Result of Impurity ( Y / N / NA ) Y → Is it the same as Approved API or Product? ( Y / N )
	□ Data on residual solvents ( Y / N / NE ) □ Raw data of batch analysis of residual solvents ( Y / N / NE ) □ Data on organic solvent used during manufacturing process ( species, justification of usage, residual limits, actual residual amount and test method ) ( Y / N / NE )
Sample drug substances	□ Sample drug substances as necessary for the quality test ( Y / N )
※ Other Remark

Drug Master File Quality Data Check List

※ Abbriviation: Y(Yes), N(No), NA(Not available), NE(Not enough)

※ Please refer to the "Guideline to Registration of Drug Substance(KFDA Notification)" and its "Explanatory Notes" for detail requirements of each item. This check list does not contain the item on the facilities of manufacturing site.