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
It starts with a structured investigation aimed at determining 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 improved products and processes and better understanding of both.
Common weaknesses
Human error is often named as the cause too quickly. In that case, EU GMP Chapter 1 requires a justification ensuring that process, procedural or system-based errors have not been overlooked. Training as the only action then often falls short. The effectiveness check is also frequently missing. The effectiveness of actions is moreover 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 QM/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 resulting actions.
Operational QM/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.
