Single-use validation


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How to bring clarity to the testing, validation and release of single-use systems

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...

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TVR: Determining testing validation and release requirements for single-use systems through risk assessment

When testing single-use items for biopharmaceutical manufacturing, when is it appropriate to leverage vendor data, and when does the end-user need to carry out testing? Is current regulatory guidance clear and sufficient in the fast-moving area of disposables? This best practice guidance has been developed as one of a suite of tools designed to assist the industry in providing a risk-based approach to testing requirements.In the rapidly evolving area of single-use systems (SUS), the industry will benefit from standardization while leveraging risk-based approaches to testing requirements to ensure compliance of parameters that are important for the process and product quality. This document establishes best practice guidance on how to use risk-assessment methodology to evaluate the level of testing needed to qualify and release SUS.

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Single-use: Testing, validation and release (TVR) standards

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...

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