CRED Getting the CMC Dossier Right 2024

28/08/2024

What is a Finished Product Specification?

The Organisation for Professionals in Regulatory Affairs

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What is a Finished Product Specification?

• Set of criteria that a drug product should conform to be considered acceptable for its intended use and is defined as a list of: • Tests • References to analytical procedures • Appropriate acceptance criteria (numerical limits, ranges or other criteria) Identified in Quality Target Product Profile (QTPP) • Confirmed by pharmaceutical development studies and stability testing • Focus on characteristics in ensuring safety and effectiveness • Does not establish complete characterisation • FPS is part of the total Control Strategy (CS) that ensures product quality and consistency • FPS includes Critical Quality Attributes (CQA) •

• Confirms the quality of the drug product when tested

The Organisation for Professionals in Regulatory Affairs

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