The safety of raw materials is critical to the production process of drugs. Scientific knowledge and risk analysis should be known for every material that goes through the production process in biopharmaceuticals. As materials are chosen, it should be understood what the purpose is of the materials as well as their sustainability. In order to understand this, Anurag S. Rathore, PhD, and Duncan Low of International Biopharm state that the supplier's manufacturing processes, quality systems, and sourcing strategy should all be included when designing the management of raw materials.The article sets out three specific kind of raw materials and how their importance should affect their quality by design process:
- - Critical raw materials are known to significantly affect product quality and these raw materials are therefore thoroughly characterized and their mechanisms of process interactions well understood.
- - Key raw materials do not significantly affect product quality but do impact process consistency. These raw materials can be characterized as thoroughly as critical raw materials, but this is a risk-based decision and will depend on the platform and the product.
- - Non-key raw materials include the remaining (and majority of) raw materials. These materials are handled through the internal quality system of the biopharmaceutical manufacturer as in traditional pharmaceutical manufacturing.
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