In this workstream, we consider best practices for environmental monitoring risk assessments, sample locations and sampling methods.
The absence of a clearly defined process for monitoring in a modern drug product facility
Current environmental monitoring (EM) programs (ISO5) are based on higher-risk aseptic technology which when applied to barrier systems, can introduce more risk than benefit. Modern drug product (DP) facilities need a clearly defined facility-wide process for establishing EM performance qualification (PQ) locations, how long to perform PQ monitoring, and for the transition to a routine monitoring program.
The absence of this can result in significant downtime/line stoppages, reducing line performance and capacity. The majority of glove interventions involve manipulating EM equipment, subsequently adding increased risk to product as well as contributing to a higher volume of work in EM labs.
Alignment with industry and regulators using a practical and user-defined process.
The creation of guidance addressing the four key questions for the design of an EMPQ program.
- What are the risk factors to consider?
- How to systematically assess a room with these risk factors?
- How to define risk levels?
- What are the minimum standards for monitoring risk levels?
The development of a risk assessment tool which can systematically evaluate locations within a facility/filling line ranking them according to probability of contamination has proven beneficial in adding significant value for all stakeholders in adopting a global standard.
Environmental Monitoring deliverables
More related workstreams
Our workstreams focus on the areas with the greatest impact across the industry. Led by science, our members are problem-solving today’s sustainability issues. By working with the regulatory governance community, they are also creating future-ready outcomes for the industry.
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