When testing single-use items, at what point is it appropriate to leverage vendor data, and when does an end user need to carry out testing? Is current regulatory guidance clear and sufficient in the fast moving area of disposables? And wouldn’t it be great if we had a tool that gave the industry a harmonized risk based approach to testing requirements. These are the questions that the BioPhorum Drug Substance TVR team have been addressing and will soon be publishing guidance.
Emerging tools and guidance
The Testing, Validation and Release (TVR) workstream are in the process of finalizing the development of a package of tools designed to help the industry align on expectations of testing, throughout the life-cycle of single use items. To do this, the team of end users and suppliers, have been using a risk assessment approach to come to an agreement on the initial and periodic testing that needs to be performed to adequately demonstrate the quality of single-use materials. Taking this approach has helped the end user to come to a consensus understanding of the risks that need to be assessed through the validation of single-use systems, the rationales that need to be in place, and the mitigations that can be considered to address any risks identified. What is emerging from the team’s work is a decision tree that that will give users a risk based methodology to define testing requirements for each quality critical element. For example it will help them define bioburden or endotoxin requirements, throughout a single-use items life cycle, from initial testing to periodic testing. To compliment this there will be an associated guidance document that explains how to implement and use the decision tree process in an end user organization and with your supply partners. Another tool will be the Component Validation Matrix that will help vendors to summarize and give more detailed reference on quality critical attributes and support compliance claims for assemblies based on component level data. In effect all the key reference information needed by an end user to successfully qualify single-use items. When published the team’s contributions on the component validation matrix tool will be incorporated into an updated version of the Supply Chain Template document, that was originally developed by the SUURS workstream, and forms part of the SUURS Toolkit.
What’s in this for you and the industry?
The team have worked hard on these tools as they believe that leveraging vendor data more effectively will enable organizations to save resource, time and money through a reduction in internal repeated testing of single-use items. However, doing so without sufficient justification carries a significant compliance risk and many companies have received regulatory findings in this area of testing single-use components. The root of the problem is the lack of detail in the current guidance, which fails to provide the clarity on the acceptability of leveraging vendor data, to avoid repeat testing.
The team believe that an industry wide risk based approach to assessing and documenting, testing requirements will allow companies to provide a robust and quality driven rationale to support the appropriate leveraging of vendor data. For suppliers, currently, significant time is spent responding to customer requests for component qualification information customized to a range of formats and to varying levels of detail. Using the harmonized approach in the Supply Chain Template will standardize customer requests and thus streamline, simplify and vastly reduce the time and effort to provide this necessary information to fulfil customer needs.