In the rapidly evolving area of single-use systems (SUSs), the testing of components is critical for process and product quality. However, industry currently faces some critical questions, such as when is it appropriate to rely on vendor testing data? And when should the end-user carry out testing?
With this uncertainty also comes the question of whether current regulatory guidance is sufficient? Unfortunately, the answer to this question is often ‘no’ and there is little clear guidance about what testing should and should not be performed over the lifecycle of SUS items, and by whom. The result is that end-users may either do too much testing or too little.
This situation drove BioPhorum’s Testing, Validation and Release (TVR) Workstream to write a new guidance document, Determining testing validation and release requirements for single-use systems through risk assessment.
It describes a harmonized, risk-based approach to determining testing requirements and clarifies when end-users should do testing and when they can rely on a vendor’s results. The paper contains best practice guidance on using a risk-assessment, decision-tree methodology to evaluate the level of initial and periodic testing needed to qualify and release SUSs.
“The challenges of implementing SUSs can be complex,” said Deanna Jones, Director BTS at Merck. “However, the principles of the BioPhorum workstreams allow us to come together to have common expectations, standard templates and standard work.”
“One example in the TVR Workstream is that quality of SUSs must be ensured during production. These systems cannot be verified by the user without rendering the system unsuitable for use. Therefore, the user must rely on the supplier to ensure the appropriate quality. The TVR Workstream aims to provide guidance for standard work related to the quality expectations of the end-user.”
The team has also updated the Supply chain template, part of the existing Single-Use User Requirement Toolkit. This template standardizes end-user requests for vendor testing details and thus streamlines, simplifies and vastly reduces vendors’ time and effort when providing this vital information to end-users.
The paper will help end-users reach a consensus understanding of the risks that need to be assessed when validating SUSs with any relevant mitigating actions, and creates a reliable means of evaluating vendor data vs. end-user requirements.
Jones added, “An important feature of the TVR Workstream is the risk assessment principles that ensure focus on the most important attributes for processing and patient safety. The TVR Workstream brings consistency and harmonization to the industry as well as demonstrating the due diligence that suppliers of SUSs have already performed to qualify components.”
The workstream believes that leveraging vendor data more effectively will enable biomanufacturers to save time and money by reducing the repeated testing of single-use items. However, doing so without sufficient justification may carry a compliance risk and some companies have received regulatory findings when testing these components (or not). Using the BioPhorum guide will help minimize this risk.
At an industry level, using the guide will mean that biomanufacturers will be able to use a consistent risk-based approach, which is acceptable to regulators, and that demonstrates their rationale for their testing approach. This means that industry and regulators can align their expectations of testing throughout the lifecycle of single-use items.