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

Use with the companion risk assessment spreadsheet here

Regulators require a risk-based approach to environmental monitoring (EM)… but they give no clear definition of what “risk-based” actually means.

So manufacturers have to decide for themselves how to best design an EM system to assure an environment is contamination-free – and then try to justify the many what/where/why/who/when/how questions from regulators.

But they may be unable to fully defend their monitoring routines and so merely comply with regulator requirements – and therefore will do more than is required.

Clearly, this has many downsides, so the trick is to find a balance that meets quality requirements with just the right amount of monitoring.

 The challenge

Resolving this issue has been a huge task. Many companies have tried but failed and one workstream member quoted a senior colleague in their company, who said “Good luck with this, you’ll never get it done” as they deemed it a tough task.

However, this was the aim of the Environmental Monitoring in Modern Drug Product workstream – to develop state-of-the-art, effective and efficient EM programs based on objectively calculated risks, and which are fit for all modern plants.

Initially, the team was hampered by a lack of common language and so a huge amount of effort went into agreeing a common way of thinking and talking about contamination risks. The team knew it was making progress when an early draft document received in 2018 positive feedback informally from key opinion leaders from the FDA and EMEA (European Medicines Evaluation Agency

The result is the Environmental monitoring in modern biopharmaceutical drug product facilities: a proposal for a harmonized risk-based approach to selecting monitoring points and defining monitoring plans.


The guide’s harmonized approach to risk assessment for EM has lots of benefits, including:

  • Putting product quality at the center of operations
  • Consistently applying current best practices
  • Minimizing the risk of regulatory scrutiny and non-compliance
  • Reducing risk by eliminating non-value-adding monitoring
  • Creating a foundation for continuous improvement as facilities evolve.

It means a company can develop an EM program to demonstrate it is doing not more or less monitoring than is needed, but the ‘Goldilocks’ amount, i.e. just the right amount distributed to cover the room risk profile

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