The ABC of Compliance: A Simple Framework for Pharma
During my early career in compliance, I was working at a large pharma manufacturing site that was earmarked for closure. It was critical to maintain site supply and performance, ensure quality standards were upheld, and guarantee patient safety for the next 18 months whilst ramping down supply.
At this time, we developed the ABC of Compliance and provided training to line managers and supervisors. The premise was quite simple and is still relevant today. It was a easy to remember framework that gave managers a practical way to lead. And it doesn’t just work in manufacturing. It can be applied throughout the pharma industry.
- ACT in a way that encourages compliance
- BUILD compliance into processes
- Take CONTROL if things go wrong
What does ACT look like in practice?
In pharma, culture is a leading indicator of compliance outcomes. Regulators look at leadership, not just policies and SOPs. Teams mirror what they see on a daily basis rather than what they “read and understand” as part of routine training. Managers need to be visible to their teams to reinforce good behaviour and correct poor behaviour by acting as a coach.
So ACT involves:
- Managers modelling ethical, patient-centred decision-making
- Being visible in labs, manufacturing, commercial, and cross-functional settings
- Reinforcing good behaviours, especially around data integrity, documentation, promotional claims, and safety reporting
What does BUILD look like in practice?
Pharma processes are complex. BUILD shifts compliance from being reactive to proactive. Teams are empowered to own risk rather than escalate everything upwards. BUILD aligns with regulatory frameworks such as Quality by Design (QbD) under ICH guidelines and Data Protection by Design and Default under GDPR. It involves moving from “detecting errors” to “preventing errors” through process design. This reflects MHRA’s expectation that system should be designed to minimise manual interventions and reduce opportunities for errors or manipulation.
So BUILD involves:
- Embedding compliance into processes rather than overlaying or bolting it on
- Involving teams in identifying risks and improving processes e.g. data integrity gaps, supply chain weaknesses, or risks associated with off-label promotion
- Using risk assessments, quality reviews, and cross-functional forums to flag issues early
- Implementing simple, workable controls that support scientific and commercial goals
What does taking CONTROL look like in practice?
Pharma regulators expect timely, transparent, and fully documented responses to issues. Effective CONTROL supports a learning culture where errors are corrected and the loop is closed so issues don’t recur. It protects patients, preserves trust, and drives continuous improvement.
So CONTROL involves:
- Acting quickly when something goes wrong e.g. deviations, complaints, data errors, potential regulatory breaches
- Using a systematic approach to find the root cause(s) (and not allocate blame)
- Putting in place timely CAPAS and actions plans and checking that these are effective in addressing the issue
- Communicating clearly so everyone understands what happened and what has changed
Conclusion
This approach works. The pharma manufacturing site mentioned earlier improved performance during the run-down period when manufacture was being transferred to other sites in the network. Quality issues decreased.
The ABC of Compliance is simple enough to remember and easy to scale. It’s a leadership model, aligned with regulatory expectations. And it empowers managers throughout pharma, not just compliance specialists, to shape safe, ethical outcomes.
Why not give it a go?
