This informal CPD article ‘Environmental Monitoring Gaps That Still Get You Cited’, was provided by Pharmalliance Consulting, who offer specialist support to pharmaceutical companies to maintain and increase quality compliance levels.
Most sites have an environmental monitoring (EM) program on paper. But not every site has one that works. In recent years, both EU and FDA inspectors have flagged the same repeat issues: monitoring that’s not representative, results that don’t get investigated, and trending that stops at Excel graphs. The warning letters tell the story, EM programs that fail aren’t always missing data. They’re missing action.
The Usual Suspects
When things go wrong, it usually comes down to one of these:
- Sampling the wrong locations.
- Failing to monitor during actual operations.
- No investigation of excursions.
- Ignoring gradual adverse trends.
- Recording “0 CFU” when that’s unlikely.
Inspectors are no longer satisfied with programs that tick boxes. They want to see evidence that your EM system can actually detect contamination, and that when it does, your site responds fast and effectively.
In Operation or Out of Touch
EU Annex 1 (2022) and FDA guidance are both clear: viable and non-viable monitoring must happen during aseptic operations, not just before and after. But that’s still a point of failure. Annex 1 takes this even further by requiring continuous monitoring in Grade A zones for non-viable particles, and nearly continuous viable air monitoring during operations. Not having space isn’t a defence, it’s a design problem.
The Investigation Black Hole
An EM excursion isn’t just a number. It’s a signal. But at too many sites, it ends with a vague root cause like “operator error” or “unknown.” Annex 1 demands that all excursions be investigated. “Clean the room again” doesn’t cut it if there’s no understanding of what caused the contamination in the first place.
Trending That Doesn’t Go Anywhere
Most sites have trend reports. But what are they doing with them? Too often, EM trends are reviewed once a quarter and filed away. Annex 1 says that trends should be reviewed regularly and used to adjust alert/action levels, modify cleaning frequencies, or update risk assessments. If your data shows slow increases over three months and nothing changes, that’s a gap.
Frequency and Justification
Another area that has drawn scrutiny is how facilities determine the frequency of monitoring. Some continue to sample based on old routines rather than current risk. When asked why a certain room is sampled weekly instead of daily, there is often no documented rationale. Inspectors are now asking sites to justify monitoring frequency using data, risk assessments, and historical contamination trends. Without that, the program starts to look arbitrary.
Alert and Action Levels with No Follow-Up
Several facilities have also been cited for setting alert and action levels that rarely trigger a response. In some cases, sites continue to operate with viable counts repeatedly hitting alert levels, but with no escalation, no investigation, and no adjustment to procedures. Regulators want to see that limits aren’t just theoretical, they need to prompt meaningful activity when crossed. Otherwise, they serve no purpose.
Surface Monitoring Is Often the Weakest Link
Air monitoring gets a lot of attention, but inspectors are still finding problems with surface sampling. This includes poorly chosen contact plate locations, inconsistent application pressure, or staff skipping routine points during busy shifts. In one
inspection, a site was cited after an operator admitted they “sometimes forget” to take glove prints after long operations. These gaps are often seen as cultural as well as procedural, and they tend to raise bigger questions about how seriously monitoring is taken at the facility level.
Conclusion
Environmental monitoring doesn’t stop at collection. It’s what you do with the data that regulators care about. Are you catching excursions? Are you investigating them properly? Are you learning from your trends? If your EM program isn’t driving decisions, it’s not protecting your process. And that’s what inspectors are writing up.
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References
U.S. Food and Drug Administration, 2023. Warning Letters Database, United States of America.
The European Commission, 2022. EU Annex 1, Brussels, Belgium
European Medicines Agency, 2013. EudraGMP Database, Amsterdam, The Netherlands.
