Risk Assessment for Different Formulations in a Highly Potent Drug Facility: Oral Solid Dose & Liquid Dosage Formulations

IDENTIFYING THE BIGGEST RISKS – DURING MATERIAL TRANSFERS/PROCESS STEPS

Several factors must be carefully assessed to ensure safe handling, especially for production processes involving numerous material transfers and multiple processing steps, from handling of the pure active pharmaceutical ingredient (API) to the finished dosage form.

KEY MATERIAL & PROCESS CONSIDERATIONS