To comply with FDA requirements, drug substances and drug products must comply with strict potency, purity, content uniformity, and rate of release specifications. Additionally, certain inactive ingredients in the drug product such as preservatives, anti-oxidants, and stabilizers must also be tested against specifications.

Vici develops and validates drug product test methods. Typical tests include:

• Potency assay to ensure compliance per label claim.
• In-process and finished product content uniformity assay to ensure control of quality during manufacturing.
• Impurity and API degradation product detection, identification, and qualification to ensure purity per ICH, industry standards, and FDA expectations.
• Dissolution methods to characterize drug release rate from the dosage form.
• Cleaning methods to ensure proper cleaning has been performed prior to manufacturing GMP clinical supplies.
• Preservative assay testing to ensure microbial purity.
• Nitrosamine impurities testing.

As per ICH guidelines and common industry practice, forced degradation is performed under stress conditions including acid, alkali, peroxide, heat, and UV exposure to ensure that methods are specific and stability-indicating.

Once methods are developed, phase-appropriate qualification or validation is performed per ICH standards to ensure compliance with FDA regulations. When feasible, compendial methods are utilized and methods are verified. Method validation protocols and reports are created and provided to the client or FDA as needed.