Pharma BDS/DP Quality Testing
Self-testing agency services for foreign (import) drug product/bulk drug substance and domestically produced drug product/bulk drug substance
MFDS-accredited test list (Pharmaceutical product)
| No. | category | test |
|---|---|---|
| 1 | General test | pH |
| 2 | Insoluble Particulate Matter Test | |
| 3 | Mass variation | |
| 4 | Appearance | |
| 5 | Determination of Volume of Injection in Containers for Injections | |
| 6 | Insoluble Particulate Matter Test for Ophthalmic solutions | |
| 7 | Total protein quantification | |
| 8 | Thermal analysis | |
| 9 | Microbial test | Sterility test (Membrane filter method) |
| 10 | Microbial Limit Test (Microbial enumeration tests-Spreader method) |
|
| 11 | Mycoplasma test-direct culture method, indirect indicator cell culture method | |
| 12 | Endotoxin (colorimetry) |
1) Applicable dosage form: Liquid, Injections, Irrigant, Ophthalmic solutions
2) In microbial test, MV (method validation) included
3) Able to issue the certification designated by MFDS
Self-testing agency service (Pharmaceutical product, Cosmetics, Health Functional Food, Chemical, and etc.)
| No. | Category | test |
|---|---|---|
| 1 | General test | pH |
| 2 | Insoluble Particulate Matter Test | |
| 3 | Mass variation | |
| 4 | Appearance | |
| 5 | Loss on ignition | |
| 6 | Residue on ignition | |
| 7 | Loss on drying | |
| 8 | Polyacrylamide gel electrophoresis | |
| 9 | HPLC analysis (Identification / Assay / Purity test) |
|
| 10 | Particle size analysis | |
| 11 | Zeta potential analysis | |
| 12 | GC analysis (Identification / Assay / Purity test) | |
| 13 | FT-IR analysis (Identification / Purity test) | |
| 14 | UV/vis analysis (Identification / Assay / Purity test) | |
| 15 | Water content (Coulometry) | |
| 16 | Osmometry | |
| 17 | Microbiological test | Sterility test (Membrane filter method) |
| 18 | Microbial Limit Test (Microbial enumeration tests-Spreader method) |
|
| 19 | Endotoxin (Colorimetry / Gel-clot) | |
| 20 | Cell therapy test | Mycoplasma test-direct culture method, indirect indicator cell culture method |
| 21 | Total cell number | |
| 22 | Cell viability test | |
| 23 | Adventitious virus test |
1) Applicable dosage form: Liquid, solid (powder)
2) In case of microbial test, MV (method validation) included
3) In case of HPLC quantification, MV (method validation) included with the report
4) Able to issue the report for self-testing (for reference, not submission to regulatory)