Case study

The context

As industry has embraced isolator technology for filling operations, guidance has been slow to keep pace. From an environmental monitoring (EM) perspective this has left industry with no clear guidance on how and where to apply EM in a modern drug product facility. Faced with the same questions from inspectors, industry’s EM leaders committed to present an aligned and risk-based approach to EM in modern facilities, adding value, clarity and direction to address this challenge.

The story

Leveraging face to face and virtual sessions, the team collated the issues and key challenges from the perspective of their individual companies, assessing where they saw the greatest risks, and integrating how to mitigate and monitor them. Additional questions around how, and how often to monitor, and guidance around when to revise monitoring plans were also considered. The team has put considerable effort into engagement and implementation planning. They have presented at nine global conferences to incorporate broader feedback including dedicated sessions for regulatory authorities, hosted a well-attended webinar; and worked with the PDA to include a reference to the BioPhorum method in the much-anticipated update to TR13.

Great resource that fills the lack of clear methodology for EM in industry. Ready to use resource is still an advantage in a project for new facilities’ implementation.

Remi Vaillant, LEO

The outcomes

A survey of the workstream’s membership confirms that around two thirds of BioPhorum’s members had adopted the methodology by mid-2021, with a majority of the remaining companies either awaiting the opportunity to adopt or actively engaged in planning implementation. “The EM risk assessment tool is based on scientific rationale and documented justification, provides an easy-to-follow template/instructions, and has received positive feedback within the industry and from regulatory bodies,” Hilary Chan of Takeda said, with colleague Christian Pruckner adding that the tool “is becoming an industry standard.”

Having published an updated version 2 of the approach in 2020, including a range of adoption case studies, and with added clarity arising from implementation at member companies, the approach was further promoted through a well-attended public webinar in Sep 21. The webinar effectively showcased the value of the tool, through the volume and range of questions from the audience.

Lessons learned

Applying science to problems is what the biopharmaceutical industry was founded upon. Risk-based approaches are becoming an expectation – providing a clarity in approach with clear outcomes or direction. Building on that history, this methodology is becoming widely accepted as an industry-wide ‘standard’ and has directly resulted in a reduction in the number of regulatory questions. Chan concluded, “I have been approached by colleagues and consultants in the industry commending this tool so it is certainly a best practice and will become familiar to inspectors as more companies adopt this methodology.”

The document is a very clearly designed, understandable and implementable tool, which provides a harmonized process for definition of EM sampling points for each company.

Nicola Spath, J&J