Posted on: 28th February 2019

Getting ready to implement harmonized EM risk assessment guidance

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.

Benefits

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

 Next steps

The document is open for consultation until May. Each member company has also committed to piloting the approach and one has decided that the guidance will become one of its global standard operating procedures – an important vote of confidence for the team.

 The feedback from the consultation and the pilots will inform the final version of the guide to be published by the end of 2019.

So what will success look like? Patrice Wéry of GSK Vaccines summarized this when he said: “We will know we’ve been successful when an inspector visits a site and says that they had seen the model before and trusted it.”

Despite many challenges, the team has demonstrated that BioPhorum collaboration can deliver something that hasn’t been done before. Impossible indeed.

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