Supply Chain Quality Management
This workstream allows the biomanufacturers and suppliers to develop a common understanding and standardized approach to the processes that demonstrate compliance with these regulatory requirements and also efficiencies and robustness of the approach.
Quality processes in the inbound supply chain are not standardized/harmonized which leads to compliance issues and the potential for regulatory agencies' observations
Industry invests significant resource into the need for quality assurance assessment, the process is not defined or enabling industry to be agile. as it is not defined for purpose considering the current climate. Change management of QA is not uniform and takes significant resource and risk assessments are not formalized. Definitions of responsibility can be vague. Differing approaches to quality management approach between biomanufacturers and suppliers.
Commonality of approach - standardization/harmonization between biomanufacturers and suppliers
- Reduction of wasted effort, time and resource – Time, Speed, Human, Capacity
- Aligned and defined process for the QAA
- Clear business process and defined scope for quality resource to work
- Commonality of approach to a risk-based quality review program between biomanufacturers and suppliers
- Frustration reduced (Member measurable factor)
- Reduced Deviations
- Clear definition of responsibilities within the supply chain i.e. who owns doing this work
More related workstreams
Our workstreams focus on the areas with the greatest impact across the industry. Led by science, our members are problem-solving today’s sustainability issues. By working with the regulatory governance community, they are also creating future-ready outcomes for the industry.
To find out more about how BioPhorum can help your business, enter your details below and a member of our team will be in touch.