CAPA in the pharmaceutical industry

Aaron Hoare 06 Sep 2023

Pharmaceutical CAPA management is a crucial competent of your quality management system (QMS). Without robust control of your corrective and preventive actions (CAPAs) you open your pharmaceutical QMS, and your entire organization, up to intense scrutiny.

Stamping out your non-conformances and preventing them reoccurring is at the heart of continuous quality improvement, offering a range of core benefits including:

• Improved process efficiency and patient safety
• Fewer defects, reworks and out-of-specs
• Reduced costs thanks to reducing defects, reworks and out-of-specs
• Simplified adherence to quality and regulatory demands
• A ‘right-first-time’ approach

In short: an effective, repeatable process to put things right, and keep them right is a must-have for your quality team. Sub-optimal pharmaceutical CAPA management accounts for around 40% of FDA 483 submissions – you can find out more about the most common FDA 483 observations in our recent article on the subject.

Struggling with your current pharmaceutical CAPA system? Read on for our introduction to managing CAPA in the pharmaceutical industry, or dive deeper by downloading our whitepaper on pharmaceutical CAPA below.

How should you structure a pharmaceutical CAPA system? The 4 ‘I’s

A closed-loop CAPA methodology should be implemented to deliver a standardized approach for your pharmaceutical CAPA management.

The number of individual steps and the complexity of your documented pharmaceutical CAPA system is up to you – but several core ingredients should be in place, following a “Plan – Do – Check – Act” framework. A PDCA framework is tried and tested for pharmaceutical CAPA systems.

Here are the 4 ‘I’s that should be included in any good system for CAPA in pharma in brief. But if you are interested in exploring the 4 ‘I’s further, we discuss them in greater detail in our guide to pharmaceutical CAPA and quality management.

1. Identification

The most important component of your pharmaceutical CAPA plan? Pinpointing and evaluating non-conformances in the first place.

Failure to properly identify non-conformances (NCRs) as they arise can be fatal for any pharmaceutical operation, with market recalls and regulatory fines easily stretching into seven-figure territory. This is why robust CAPA in the pharmaceutical industry is so essential.

As such, your primary focus should be to perform frequent operational checks and reviews to ‘catch’ NCRs for CAPA treatment.

Other identification sources might be external, such as third-party audits and regulatory inspections. You should also ensure you have a robust process for receiving customer complaints and feedback. A great way to do this is by running Voice of Customer (VoC) surveys, and their results can be a useful pillar in a pharmaceutical CAPA system.

Getting the systems in place for NCRs to be flagged is crucial. Equally, don’t rush into instant firefighting mode. Take the time to thoroughly collect all available information about the non-conformance in question.

2. Investigation

You’ve found a pharmaceutical non-conformance and gauged its impact. Now it’s time to pinpoint why it occurred with a thorough root cause investigation. Root cause analysis should always form the core of all CAPA in pharma activities.

A range of quality tools and techniques can be applied at this stage to your pharmaceutical CAPA system. Assemble a cross-functional investigation team to ensure different perspectives and insights are taken into account.

The objective of this stage is to consider all possible circumstances connected to the emergence of the non-conformance. We tackle these areas in greater detail in our pharma CAPA whitepaper.

3. Implementation

Investigating and uncovering your root causes will naturally set up a series of actions to correct the non-conformance and prevent its reoccurrence.

Put together a detailed pharmaceutical CAPA action plan to implement. List each action and task to be completed, along with any necessary changes to your processes, procedures or information streams – making sure the outcome and rationale for the change is fully documented.

4. Internal review

Performing an internal audit as part of your pharmaceutical CAPA system is crucial. You should be asking:

• Has the root cause of the initial non-conformance been addressed?
• Has the non-conformance reoccurred?
• Have all steps of the CAPA plan been actioned – and might they have any adverse effects on other areas of the business?
• Has the corrective and preventive action worked?

Answering these questions is the crux of the 4th ‘I’ – the internal review. In short, the efficacy of your CAPAs should be checked and rechecked before close-off. If you’re interested in tips for good internal auditing, you can watch our recent webinar on auditing skills.

Put in place any long-term monitoring you feel is appropriate. Then it’s time to move onto the next NCR.

Make your pharmaceutical CAPA management system even stronger

Dealing with multiple CAPAs at once? Struggling to align your quality processes? Worried some non-conformances are slipping through the net?

Consider a dedicated CAPA software platform, such as Ideagen Quality Management.

Centralize your information streams to make NCR identification simpler.

Use powerful business intelligence dashboards to get under the skin of quality issues and unpick the root cause.

Then build automatic digitized workflows to funnel actions to the right people at the right time for targeted pharma CAPA management – all with complete end-to-end visibility.