Master ATMP processes by controlling raw and starting material

Advanced Therapy Medicinal Products (ATMPs) must be safe, effective and of a high quality when administered to the patient. To achieve this, the activities carried out at each stage of the ATMP manufacturing process including supply chain must be controlled and standardized wherever possible to ensure safety of the finished product. In this context, the quality of starting and raw material is a key factor to consider especially in the ATMP field where the raw materials and starting material usually come from very different sources and include some of human origin. Regulatory frameworks are already in place for supporting raw material and starting material process control. The criticality of each raw material and starting material should be assessed using a risk-based approach. Following this evaluation, a control strategy should be defined. Ensuring reliable raw and starting material will allow consistency and performance of every batch and so a sustainable quality of the drug product.

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