Environmental monitoring (EM) programs are an effective tool in assessing the state of control in classified manufacturing areas. They are a vital part of the quality system in all modern drug production facilities and are scrutinized by regulatory agencies.

However, designing an EM program is a relatively complex task; facilities vary considerably, there is inadequate specific guidance on how to design one and no single standard risk assessment methodology exists.

Each facility and regulatory agency inspector must determine the specific risk factors for microbiologic contamination and the adequacy of monitoring.

Whilst there are many tools available, there is no consensus on best practices for an EM risk assessment and hence the need for a globally aligned approach has never been greater.

The benefits of a risk-based approach

All of this and more is discussed in an article called Establishing Best Practices For Risk-Based Environmental Monitoring Of Modern Drug Product Facilities.

The article was written by a member of the Environmental Monitoring Workstream – Dawn Watson, Director of Engineering at Merck & Co., Inc. It discusses how an industry standard would reduce the need for individual judgment, ensure minimum sampling requirements for all high-risk locations and enable the adoption of best practices across the industry. Moreover, as facilities modernize, a standard would provide a framework for developing EM programs in line with technological improvements.

The article guides readers to an updated version of BioPhorum’s risk-based guidance, A Harmonized Risk-Based Approach to Selecting Monitoring Points and Defining Monitoring Plans.

The updated guide includes revisions in response to feedback and additional context from a series of case studies that adds significant value for all stakeholders in adopting a global standard.

The approach captures best practices in a useable ‘toolkit’ format, incorporates good practices from 30 subject matter experts from 16 biopharmaceutical manufacturers and adheres to current regulatory guidelines, e.g. ISO 13408-1, the FDA’s Aseptic Processing guidance and EU guidelines to good manufacturing practice Annex 1.

“This is a great resource for the entire industry to use for risk assessments when preparing for Environmental Monitoring Performance Qualification execution,” said Fred Ayers, Research Scientist at Eli Lilly and Company. “Lots of cross-company dialogue within the EM Workstream to get this document out to the public. Great work by all members of the team!”

Regulatory acceptance and industry implementation of this harmonized approach will lead to many 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.

Using the updated BioPhorum guidance means doing just the right amount of monitoring needed – no more, no less. Now, doesn’t that make good business sense?