In detail
Legal basis
ICH Q10 describes the CAPA system as one of four elements of the pharmaceutical quality system, alongside process performance and product quality monitoring, change management and management review. In the EU GMP Guide, Chapter 1 requires an appropriate level of root cause analysis for deviations, suspected product defects and other problems, and appropriate CAPAs to be identified. Their effectiveness must be monitored and assessed on a risk basis.
Where CAPAs come from
According to ICH Q10, CAPAs result from the investigation of:
- complaints, product rejections and recalls
- deviations and non-conformances
- audits, regulatory inspections and their findings
- trends from process performance and product quality monitoring
Process
The process starts with a structured investigation to determine the root cause. The level of effort, formality and documentation should match the risk, in line with ICH Q9. Where the true root cause cannot be determined, EU GMP expects the most likely root cause to be identified and addressed. Actions are then derived, implemented and checked for effectiveness. Process changes resulting from CAPAs go through change management. ICH Q10 applies CAPA throughout the lifecycle: in development, in technology transfer, in commercial manufacturing with evaluation of effectiveness, and even after product discontinuation, considering product remaining on the market. The aim is to improve products and processes and to understand both better.
Common weaknesses
Human error is often named as the root cause too quickly. In that case, EU GMP Chapter 1 requires a justification showing that process, procedural or system-based errors have not been overlooked. In such cases, training as the only action often falls short. Effectiveness checks are also frequently missing, even though the effectiveness of actions is part of the annual product quality review under Chapter 1.10 and of management review under ICH Q10.
In practice at A&O Pharma
As part of our operational QA support, we take on ongoing tasks such as deviations, CAPA, change control, complaints and self-inspections. We also support you with GxP audits and regulatory inspections, including the actions that result from them.
Operational QA SupportFrequently asked questions
What is the difference between corrective and preventive action?
According to the definition in ICH Q10, a corrective action prevents the recurrence of a detected non-conformity, while a preventive action prevents a potential non-conformity from occurring in the first place.
Does the effectiveness of a CAPA have to be checked?
Yes. EU GMP Chapter 1 requires the effectiveness of corrective and preventive actions to be monitored and assessed in line with quality risk management principles.
Is human error an acceptable root cause?
Only with justification. Under EU GMP Chapter 1, it must be ensured that no process, procedural or system-based errors have been overlooked before human error is recorded as the cause.
