In the final part of our five part series of Quality Risk Management per Annex 1, we explore the benefits of a Cleanroom Process Risk Assessment and how our Contamination Control Advisers can provide you with one.
Process Risk Assessment: Why it’s important
A process risk assessment helps you to to ensure risks are properly controlled. Without a risk analysis:
- you may have too many or too few sampling points.
- You may not be able to correlate the data with the operations
- The data may not be usable in the case of an investigation or trend analysis to define alert and action levels
- There may not be a correlation between the positioning of the particle counters and the active air samplers
- The particle counters could be disturbed by movement of machinery during operations
- The heights may not be properly defined
While the final wording of EU Annex 1 is not yet released, the message is clear: European health authorities and inspectors will seek scientifically sound, unbiased risk assessments, and the use of QRM principles in the planning, design, control, monitoring, operation, and investigation of sterile product manufacturing processes. The industry must be prepared to develop and employ those QRM principles and risk management methods.
Learn how our Advisory Services Team can help you with a Cleanroom Process Risk Assessment.
Want to read more? Jump to other released posts in this series:
- Part 1 of 5: Quality Risk Management- Principle Section 2
- Part 2 of 5: Quality Risk Management- Annex 1 section 6.1
- Part 3 of 5: Viable and Non Viable Environmental and Process Monitoring- Annex 1, Section 9.4
- Part 4 of 5: Definition of potential sampling points
- Part 5 of 5: Process Risk Assessment (you are here!)
See links to additional supporting resources below:
- Paper: Choosing the Most Suitable Particle Sample Point Locations in the Cleanroom
- On-Demand Webinar: Case Study: Developing an Isolator Filling Line using a Quality Risk Management Approach
- Blog series: How to Achieve Quality by Design (QbD) in a new Pharmaceutical Fill Line: Intro and Regulatory (Series Part 1 of 6)
Don’t miss an episode of this series. Register for updates on the right column of this page. Click here to contact our Experts for questions.
Particle Measuring Systems has complete cleanroom contamination control solutions to help you meet EU GMP including:
- Our Contamination Control Advisory Services who can conduct an expert Risk Assessment for your pharmaceutical processes
- PMS cleanroom particle counters including portable/mobile and fixed/remote
- Microbial monitors including portable/mobile, fixed/remote, and single use.
- Data management software from Particle Measuring Systems
- Customizable, turnkey Facility Monitoring Systems (FMS)
More EU GMP Annex 1 Information
Three Core Events to Establish Environmental Contamination Control – Per EU GMP Annex 1
Microbial Monitoring Solutions to Prepare Your Contamination Control Strategy (CCS) for ANNEX 1
Potential Cleanroom Sampling Points per Annex 1 Draft (Part 4 of 5)
Life Sciences & Pharmaceutical Industry Contamination Control
Annex 1 Single Use Systems (SUS) Requirements & the BioCapt Single Use Impactor