Environmental Monitoring (EM): A harmonized risk-based approach to selecting monitoring points and defining monitoring plans

This guidance  comprises a methodology which addresses the four key questions for the design of an Environmental Monitoring  Performance Qualification (EMPQ) program and subsequent routine EM program:

  1. What are the risk factors to consider?
  2. How to systematically assess a room with these risk factors?
  3. How to define risk levels?
  4. What are the minimum standards for monitoring for different risk levels?

The risk assessment tool systematically evaluates locations within the facility/filling line against standard environmental control elements to determine which areas have the most potential for re-contamination of isolators or contamination risk of rooms during routine manufacturing processes. The six factors identified are:

  1. Amenability of equipment and surfaces to cleaning and sanitization
  2. Personnel presence and flow
  3. Material flow
  4. Proximity of open product or product contact material
  5. The need for interventions/operations by personnel and their complexity
  6. The frequency of interventions (only applicable for grade A)

The guidance document describes how to use these six factors to systematically assess all areas of a room and ranks them according to probability of contamination. A set of principles and minimum standards are then proposed to determine where to locate sampling points and select sampling methods to match risk levels.

This second edition of the  guidance includes revisions in response to feedback, and incoporates context from a series of case studies, which adds significant value for all stakeholders in adopting a global standard.

Dawn Watson summarizes  the importance of the work completed by the team on best practices for establishing a risk-based approach to routine EM in an article published in BioProcess Online on 3 February 2021

 

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EM Risk assessment tool template-v2 Nov 2020.xlsx
EMinDP A harmonized risk-based approach to selecting monitoring points and defining monitoring plans November 2020.pdf
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  Annex 1     environmental monitoring     environmental monitoring in drug product (EMinDP)  
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