• Physical appearance
• Identity (qPCR, sequencing)
• Purity
• Titration
• PH
• USP Sterility
• USP Bioburden
• Host cell DNA content
• Endotoxin levels
• Total protein content

• Establishment of specifications
• Establishment of reference material
• Characterization of reference material
• Method familiarization
• Method development
• Qualification protocols
• Execution of qualification/ validation
• Qualification reports
• In-process testing
• Release testing: raw materials, banks, DSs, DP

• Stability testing
• Master batch records
• Vendor qualifications
• Water runs
• Engineering runs: Media fills
• Drugs products (CTM)
• Placebo (CTM)
• Pharmacy manual