You’ve just been notified of a regulatory inspection.
The Managing Director asks: are we inspection-ready?
If the answer isn’t immediate and backed by data, you’re not.
Inspection readiness
Inspection readiness is often treated as an activity. Something you prepare for once the notification arrives.
In reality, it isn’t.
Inspection readiness is a condition. It exists when a Marketing Authorisation Holder operates an effective Pharmaceutical Quality System (‘PQS’) in place, aligned to EU GMP Chapter 1 and 21 CFR, and is operating in a continuous state of control as defined by ICH Q10.
That’s the theory. The question is whether it holds up in practice.
Regulatory inspections
Regulatory inspections are a normal, albeit infrequent, part of operating in a GMP environment. They are not exceptional events. They are checkpoints.
Inspectors assess your ability to meet GMP requirements, but they do not look at isolated activities. They look at the system as a whole. The interconnectedness of your PQS is what they are really testing.
They use sampling techniques to assess key control points. They follow the data. They follow the decisions. They follow the links between systems.
And importantly, they review far beyond manufacturing. Stability, pharmacovigilance, market surveillance, licence commitments. All of it feeds into their view of control.
In that sense, an inspection is not the start of scrutiny. It is the final step in a long chain of GMP governance.
Establishing and maintaining a state of control
If your processes are defined, your control points are clear, and performance is being monitored, then your Management Review should already tell you whether you are inspection-ready.
Not perfectly compliant. That’s not the point.
But demonstrably in control, with risks understood and managed within acceptable limits.
A simple test is this.
Can you say, based on current data, that:
- The PQS has been in a state of control over the past period
- You are confident to proceed with manufacturing today
Or conversely:
- You are trending out of control
- And corrective action is required before continuing
If you can’t answer that clearly, then inspection readiness becomes guesswork.
In reality, this is what Management Review should be doing. Providing a regular, data-driven assessment of control that senior leadership can rely on.
But that raises a harder question.
- How do you know your control points are the right ones?
- How early do they detect loss of control?
- Are they preventative, or simply reporting failure after the fact?
Beyond the obvious metrics, what are you monitoring?
- Quality culture
- Competence
- Staff turnover
- Alignment of SOPs to GMP requirements
And critically, are all elements of the PQS working together, or pulling in different directions?
If the objective is to consistently produce compliant batches, are you actually trending that capability?
Auditing as a state of control pressure test
Auditing should provide an independent view of whether your PQS is achieving and sustaining a state of control.
In practice, the same issues come up time and again:
- Audit programmes not aligned to control points
- Management Review not assessed
- PQS interfaces ignored
- Weak auditor capability
- QA owning corrective actions
Invert those, and you have the blueprint for an effective audit function.
Auditors should not operate purely at SOP level. If the SOP does not align to GMP, auditing against it adds little value.
GMP is the baseline. Auditors need to understand it, apply it, and challenge against it.
Equally, ownership matters.
The auditee owns compliance.
The auditee owns corrective actions.
Inspectors will not tell you how to fix deficiencies. Auditors should not fall into that trap either.
Where auditors or QA take ownership of solutions, accountability becomes blurred and effectiveness suffers.
Auditing is not inspection. It goes deeper.
Internal auditors have greater access to data, more time to understand processes, and the ability to focus on specific areas of the PQS throughout the year.
Used properly, auditing becomes a continuous pressure test of your state of control, not a periodic checklist exercise.
Auditor competence and capability
Auditor capability is often underestimated.
A technically strong auditor understands not just how to audit, but what “good” looks like in a functioning PQS.
This includes:
- Using GMP requirements as the starting point
- Assessing whether Management Review is genuinely effective
- Challenging senior management on their responsibilities under Chapter 1 and ICH Q10
- Designing audit programmes that align to business risk and control points
- Writing findings that are clear, actionable, and owned by the process
For many organisations, this level of maturity takes time to build.
In some cases, it requires external support to benchmark current capability and identify gaps.
So, are you inspection-ready?
The Head of QA’s response to the Managing Director should not rely on last-minute checks or inspection preparation teams.
It should be grounded in evidence:
- The PQS is designed with defined control points
- Management Review monitors those control points with data
- Process owners understand and report on their areas of control
- The audit programme independently verifies effectiveness
- Risks and non-conformances are identified early and owned by the business
At that point, the question changes.
Not “are we ready for inspection?”
But:
Are we in control?
And can we prove it?
Inspection readiness isn’t proven the week before an inspection.
It’s proven every week in your Management Review.
And if that process isn’t working, the inspection will show you.
How MOAT supports organisations
At MOAT, we support organisations in strengthening inspection readiness through practical, system-based approaches that stand up under real inspection pressure.
If you’re not fully confident in your current state of control, now is the time to test it — before the inspector does.
Training and support
- Introduction to Good Manufacturing Practice
- GMP Internal Auditor
- Introduction to Good Distribution Practice
We also run bespoke onsite and online training sessions for pharmaceutical companies throughout the year. If you are interested in a tailored course, please get in touch by emailing enquiries@moat.ie
For more information on training, visit: https://moat.ie/services/training/training-life-sciences/
About the Author
This article was produced by MOAT in collaboration with Peter Deegan, a GMP expert with over 30 years’ experience in quality systems and auditing. Peter has led auditing programmes across the pharmaceutical sector, supporting organisations in strengthening inspection readiness through practical, system-based improvements.