From Box Ticking to Regulatory Readiness: Reflections from the Cork Biopharma Forum

Feb 6
4 min read

On paper, most organisations can point to a Contamination Control Strategy, supported by procedures and risk assessments, with clear links into the quality system. From a distance, the framework looks sound.

The challenge usually appears later, when inspectors stop reviewing documents and start asking people to explain how contamination risks are actually controlled day to day. At that point, even well-established systems can begin to feel fragile.

This is not a skills gap. It is a structural one. The way contamination control has historically been assembled does not always match the way regulators now examine it.

Close-up view of a laboratory with scientific equipment — Professionals Sitting in a Conference Hall.

How Regulatory Focus Has Shifted in Practice

Recent inspection experiences across sterile, non-sterile, and ATMP manufacturing have reinforced a consistent theme: the existence of a contamination control strategy is no longer the point of interest.

Inspectors are increasingly focused on whether the organisation understands its own control model.

They want to hear how contamination risks were identified, why certain controls were chosen over others, and how the organisation knows those controls continue to work. They test whether monitoring data, deviations, and operational decisions support the story being told.

This approach is being applied consistently, regardless of manufacturing type. While the technical risks vary, the expectation for clear reasoning, ownership, and evidence does not.

Where Confidence Tends to Break Down

When inspection discussions become uncomfortable, it is rarely because something is missing. More often, it is because different parts of the system do not line up.

Controls may exist without a clearly articulated rationale. Risk assessments may rely on judgement that is difficult to explain consistently. Strong local practices may not be visible at system level. Deviations may quietly undermine assumptions that the CCS presents as fixed.

Individually, these issues can seem minor. Taken together, they create uncertainty. Once that uncertainty is visible, inspectors naturally probe further, and the CCS can quickly shift from reassurance to risk.

Re-Positioning Contamination Control

Organisations that navigate this scrutiny well tend to share one common trait: they do not treat contamination control as a document set.

Instead, contamination control is understood as an operating model that governs how risks are prevented, detected, and managed across the organisation.

In practice, this means that controls are viewed as interconnected rather than standalone, decision-making logic is shared beyond QA, and ownership of contamination risks is clearly understood. The CCS then serves a specific purpose: it explains how that system works and how it is kept under control.

This change in perspective makes a significant difference during inspection. Conversations become easier because the organisation is explaining how it operates, not defending how it documented itself.

The Effect Beyond Inspection Rooms

When contamination control is approached as a system, the benefits are not limited to regulatory interactions.

Organisations often see stronger engagement from operations and engineering, more consistent explanations across functions, and earlier recognition of emerging risks. Instead of responding to inspection findings, teams are able to identify weaknesses through their own governance and data.

For organisations working across multiple sites or modalities, this consistency becomes critical. Without a shared way of thinking about contamination control, variation naturally increases, along with inspection risk and internal effort.

One Framework, Many Applications

A common concern is that taking a holistic approach will force standardisation of controls. In reality, successful organisations do the opposite.

They standardise how decisions are made, not which controls are used.

A clear operating framework typically defines who owns contamination control decisions, how risks are assessed, how controls are justified, what evidence is expected, and how the system is reviewed over time. This framework can be applied across sterile, non-sterile, and ATMP environments, even though the hazards and controls themselves are very different.

Readiness is Demonstrated, not Written

Regulatory readiness is evident when an organisation can clearly and confidently explain how contamination risks are controlled, supported by data and governance that reinforce that explanation.

When this clarity exists, documentation becomes easier to maintain, not harder. Decision-making accelerates, alignment improves, and contamination control stops being a reactive topic raised during inspections.

It becomes part of how the organisation operates.

Looking Back at the Cork Discussion

These points were discussed in detail at the Biopharma & Life Sciences Connected event in Cork on 22 January, during the session:

“Contamination Control: From Box Ticking to Regulatory Readiness.”

The session explored how regulators are currently assessing contamination control, why the same expectations apply across manufacturing types, and how organisations can move from fragmented approaches to a coherent, defensible system. A case example was also shared, showing how a global CDMO aligned multiple sites and modalities under regulatory pressure.

If you missed the talk in Cork, a recording is available on the Pharmalliance YouTube channel.👉 https://youtu.be/kQjOXvQFO4M?si=Si2-a2SBk8qrloM2

For quality, compliance, and operational leaders, the question is no longer whether contamination control documentation exists. It is whether the organisation can explain and defend how contamination is controlled when challenged.

That difference is what separates box ticking from regulatory readiness.

Need expert support improving your Contamination Control program?

Pharmalliance Consulting Ltd works with life sciences organisations to strengthen compliance frameworks, prepare for inspections, and embed quality across operations.