• Process Validation for Accuracy, Precision, and creditability of product with USP and ICH Guideline

• Test for deciding to release API and final product

• Establish the term of validity and condition of preservation for Drug substance and Drug product

• HVAC(Air) Monitoring
• Water(PW, WFI) Monitoring
• Gases(Compressed Air, N2, CO2, O2) Monitoring

Eligibility test of materials

Biochemical Test	IEA, SDS Page/Westen Blot, EIA, HCP, etc
Chemical Test	HPLC(Including SEC, RP, IE) Peptide mapping, GC, Amino Acid Content, N-tetminal sequencing, C-terminal sequencing, Scanning Densitometey, pH, Particulate Matter Reconstitution/Appearance, conductivity, TOC, etc
Microbial Test	Sterility, Endotoxin, Bioburden Mycoplasma Total Microbial Count, Microbial Identification, etc
Bioassay	Cell-based bioassay/Mycoplasma, Potency, etc