- Well-experienced staffs in Quality Assurance Department educate the GMP to whole related members periodically and repeatedly.
- Staff who have experienced FDA and EU audits, as well as outside instructors, provide on-the-job training to enhance the quality-consciousness of Nippon Fine Chemical employees.
- NFC enthusiastically accepts audits by outside corporations and entities to allow them to be sure of NFC's quality assurance system.
- Quality control system could be complied with c-GMP on FDA standard basis.
- Both chemical and microbial analyses could be available.
- Stability test based on ICH guideline could also be available.
- The protocols and reports would be issued.
Principal Characteristics Examined
- GC, HSGC (residual solvents), IR, NMR, UV
- HPLC (including chiral compounds), DSC, TGA, fluorometry, melting point
- Water content, optical rotary power and physicochemical analyses
- Suspended fungi, attached fungi, and mold count analyses
- Analyses according to USP, NF, EP, and JP