A user requirement specification (URS) for equipment, facilities, utilities and systems should define all the requirements needed to create a feasible design to meet a system’s purpose. It should ensure that essential quality elements are built-in and any risks to good manufacturing practice, product quality, and patient safety are mitigated. Success relies on a clear, shared, industry-wide understanding of definitions and requirements.
However, the regulatory landscape is unclear and how definitions are understood and applied is inconsistent. As a result, URSs are often overly detailed, produced at differing points in the process, and are sometimes only approved after equipment has been fabricated.
Industry needs a way to ensure greater clarity, consistency and implementation of lean URS procedures throughout the validation lifecycle that will result in reduced waste and time – for the ultimate benefit of patients.
BioPhorum’s Lean Qualification and Validation Workstream took on the challenge and has published a paper, The user requirement specification (URS) of the future, that details a new URS solution containing
- A defined, collaborative approach to devising a URS
- An improved industry-wide understanding of URS content, structure and lifecycle
- A URS template.
“The team analyzed the content of more than 40 URSs, reviewed best practices seen in industry, and explored good record-keeping practices for URS documentation,” said Alejandro Parisi, Validation Network Lead at Roche/Genentech and one of the authors of the paper. “The lessons learned enabled the team to design a template for the URS of the future.”
We also surveyed the same member organizations to explore industry best practices and respondents were asked to use a URS for a typical autoclave as a benchmark. Our findings include
- There are variations in authors and approval requirements across organizations
- Some organizations do not use standard templates and do not use the URS as a living document, as required in health authority guidelines
- The timing for creating a URS is inconsistent
- There are variations in length, content, and specified operational aspects in the URS, and previous attempts to standardize have been unsuccessful.
“More generic and standardized URSs will help projects drive faster by bringing both the tendering and qualification processes forward,” said Lars Hovmand-Lyster, Senior Engineering Specialist at Novo Nordisk. “This will happen if suppliers receive more standardized documents that are commonly agreed across the manufacturing industry.”
Overall, we found that industry would benefit from a consistent approach to categorizing user requirements and robust version control of revisions. Achieving this will be a huge challenge. So, if you have any responsibilities for the qualification and validation of biopharmaceutical manufacturing plants – such as engineering, qualification/validation, and quality oversight – then this paper is for you.
“The purpose of this ‘URS of the future’ is to stimulate debate in the biopharmaceutical industry,” said Parisi, “and to work towards industry-wide alignment on the creation and use of optimized and lean URSs for equipment, facilities, utilities and systems qualification.”
Implementing lean URSs throughout the qualification lifecycle will reduce waste and time. Working together, we can start a journey toward alignment and implementation of the URS of the future. How do you use URSs in your organization?