Risk assessment and control of single-use system (SUS) is a key element of concern for both pharmaceutical companies and regulatory agency. Pharmaceutical companies need to assess the potential risks of SUS used in the manufacturing process to avoid possible safety impacts on patients. SUS may have the possibility to change in order to ensure the safety, efficacy and quality of drugs during both R&D and commercial manufacturing. For different changes occurred in different lifecycles of drugs and different stages of manufacturing process, there are different impacts on the quality, safety and efficacy of drugs, and the category of changes are also different, so it is necessary to evaluate the risk of changes scientifically and reasonably.
- ✔ Comprehensive process flow for one-time use system risk assessment: the entire process flow is considered to conduct a risk assessment of the one-time use system.
- ✔ Multi-dimensional correlations, fully considering drug quality, safety, and efficacy: Various aspects are taken into account to ensure drug quality, safety, and efficacy.
- ✔ Based on science and risk, multiple risk assessment models are employed: Risk assessment is carried out using scientific and risk-based models.
- ✔ Professional team providing regulatory interpretation, technical support, and document writing: A professional team is available to offer regulatory interpretation, technical support, and document writing services.
- ● Full-package of risk assessment on SUS used in the whole manufacturing process
- ● Comprehensive consideration to make sure the quality, safety and efficacy of drugs
- ● Multiple models and ways to conduct risk assessment
- ● Professional technical team to provide regulatory interpretation, technical support and document initiation