Why Your Microbial Control Program Is No Longer Enough - USP 1110 is Coming...

If you’re a Quality Director, Sterility Assurance Lead, or Qualified Person in a regulated pharmaceutical or biologics manufacturing facility, there’s a quiet shift happening in your regulatory landscape and it’s already putting companies on the FDA’s radar.

That shift?

The updated USP <1110>: Sampling for Microbiological Control.

And if your microbial monitoring program hasn’t been updated with this in mind, you’re already behind.

QC Microbial Testing in Progress.

Legacy Environmental Monitoring Can’t Keep Up

For years, many facilities have relied on static, one-size-fits-all environmental monitoring (EM) programs: fixed sampling points, predefined frequencies, and legacy SOPs that were “compliant enough” to fly under the radar.

But that’s no longer enough.

The revised USP <1110> aligns more closely with EU Annex 1 (2022) and ICH Q9(R1). It makes one thing very clear: microbial control must be built on risk-based rationale, not routine. Sampling locations, frequencies, and methods now need to reflect product-specific risks and facility-specific process understanding.

What does this mean for you?

• You must justify your sampling strategy using science and risk.

• You need a Contamination Control Strategy (CCS) that integrates with your EM plan.

• And you need to train your team on the “why” behind microbial control and not just the “how.”

Failure to do so invites 483 observations, recalls, or worse: product contamination events with real patient consequences.

Compliance Gaps You Can’t Ignore

You’ve probably tried to patch these issues already:

• Updating SOPs for EM locations without a risk assessment.

• Hiring generalist consultants who offer recycled templates.

• Telling staff to "sample more" when excursions occur without revisiting root causes.

These efforts may feel like progress, but they don’t meet the regulator’s evolving expectations.

The FDA and EMA are now looking for holistic microbial control programs that show traceable logic from Contamination Control Strategy → Environmental Monitoring Plan → Risk Assessment → Action.

Anything less is just ticking boxes.

In fact, many FDA Warning Letters now explicitly cite failures to:

• Justify EM sampling points and frequency.

• Demonstrate CCS alignment with manufacturing risk.

• React appropriately to microbial excursion trends.

Regulators are not just asking “Did you monitor?”They're asking: “Did you monitor the right places, at the right times, for the right reasons and act accordingly?”

What You Really Want

You want to know that your microbial control program will hold up to scrutiny, even during the most intense inspection.

You want:

• A Contamination Control Strategy that’s aligned with Annex 1 and USP <1110>.

• A scientifically justified EM program that’s defensible and dynamic.

• A trained team that knows why microbial control matters and not just what SOP to follow.

• A way to implement all this quickly, without disrupting production or draining your resources.

Pharmalliance Consulting Ltd and the CCEP Advantage

At Pharmalliance Consulting Ltd, we specialize in one thing: Contamination Control.

Not validation, not serialization, just the expert implementation of contamination prevention programs in sterile and non-sterile environments.

And our signature offering, the Contamination Control Excellence Program (CCEP), delivers exactly what companies like yours need:

✅ Creation and Deployment of Your Contamination Control Strategy

Most companies struggle with creating a living CCS. We don’t. CCEP includes full CCS framework templates, implementation plans, and evaluation tools, all pre-populated and proven to pass regulatory scrutiny.

✅ Cross-Functional Team Training on Contamination Control

Your operators, engineers, and QA staff will finally understand contamination control and not just follow instructions. Our training covers scientific principles, real-world case studies, and how to recognize and prevent risks before they escalate. Our 35 online modules give you everything you need to Educate, Execute and Elevate your contamination control efforts.

✅ Full Regulatory Alignment — Fast

We deliver this transformation in just 8 to 12 weeks. And we’ve done it successfully for ATMPs, CDMOs, and global pharma manufacturers with zero CCS-related inspection findings.

What Makes Pharmalliance Different?

We’re not just another GMP consultancy.

Here’s what sets us apart:

• 🧪 Contamination control is what we do. We live and breathe sterile manufacturing, cleanroom risk, and CCS frameworks.

  
  

• 📚 Our training materials are built from EU Annex 1, USP <1110>, PDA TR90, and FDA guidance — not guesswork.

  
  

• 💻 Digital-first, outcome-focused. The CCEP is available online, onsite, or hybrid and includes 35+ modular topics with expert coaching.

Take Control Before Contamination Takes Control of You

With Pharmalliance Consulting Ltd, you can turn regulatory change into a competitive advantage.

Let us help you move from reactive fixes to proactive control.

Visit https://www.pharmalliance.ie/ccs-excellence learn more about our Contamination Control Excellence Program

Because compliance isn’t just about ticking boxes, it’s about protecting patients, products, and your reputation.