We all know that pharma companies are duty-bound to control the quality of the drugs they produce—it's paramount for protecting patient safety. One critical part of how they do this is by employing a Corrective and Preventive Action (CAPA) system.
CAPA is a systematic approach for identifying quality issues with products and then fixing those issues so they don’t happen again. Pharma companies (like other life sciences organizations) must have an effective CAPA process to meet regulatory requirements.
Quality professionals working in pharma need to understand CAPA, particularly key regulatory expectations and best practices. In this post, we’ll explain why CAPA is important to pharma, explain the role of CAPA in pharma, and provide seven best practices if you’re new to CAPA in pharma.
What is CAPA in pharma?
The CAPA process is a quality assurance technique to identify and deal with product quality issues. It’s used by companies across a whole host of industries, including pharma companies.
When it comes to CAPA in pharma, it’s an essential tool that forms part of Good Manufacturing Practices (GMP), a set of regulations that drug manufacturers must comply with to ensure product quality.
CAPA systems identify, address, and prevent issues with drug products, such as deviations or nonconformities in manufacturing procedures. A rigorous CAPA process ensures that the root cause of a problem is understood through well-defined and logical steps so that it can be fixed and prevented from happening again.
As you might have guessed from the name, CAPA involves two main components:
- Corrective Action is a reactive approach that addresses existing problems. It resolves or prevents the recurrence of immediate problems.
For example, fixing audit findings and responding to deficiency or warning letters from regulators. - Preventive Action is a proactive approach focusing on preventing problems before they happen.
For example, by conducting regular risk assessments or analyzing trends in data and taking action to reduce the risk. Identifying the sources of past warning letters is a great way to tackle them proactively.
By systematically applying CAPA, it becomes a tool to support continuous process improvement. Nonconformities are fixed quickly, product quality is maintained, and patients are safeguarded.
You can watch our Scilife Academy video below to get a more detailed introduction to Corrective and Preventive Actions.
CAPA compliance in the pharmaceutical industry
Pharma companies must comply with regulatory requirements for CAPA, which vary from country to country. A well-defined and thorough CAPA system shows regulators that a company takes quality seriously and can reduce the risk of non-compliance. If companies fail to comply with their CAPA obligations, they may face hefty fines, product recalls, and damage to their reputation.
Regulations for CAPA systems depend on where products are produced and marketed:
- FDA 21 CFR Part 820: In the United States, pharma companies are regulated by the Food and Drug Administration (FDA), which mandates CAPA procedures as part of GMP requirements.
For pharma, CAPA isn’t well documented, which can be frustrating for legal and compliance teams who don’t like grey areas! Because of this, many organizations refer to medical device regulations, FDA 21 CFR Part 820, which detail CAPA expectations more thoroughly.
During FDA inspections, if an auditor notices an issue that needs fixing, they’ll issue an “Inspectional Observation,” otherwise known as an FDA 483. Following this, a company has 15 days to respond with a full CAPA plan detailing how they’re going to fix the issue. - EMA Eudralex Volume 4: In the European Union, the European Medicines Agency (EMA) regulations for pharma manufacturing are EudraLex Volume 4, and they include strict CAPA requirements, involving a systematic and thoroughly documented approach.
In addition to complying with regulations, there are important international guidelines that can help pharma companies build a reputation for quality and help ensure drugs are marketable internationally:
- ICH Q10: The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q10 is a guideline for Pharmaceutical Quality Systems (PQS). Reputable pharma companies that adhere to ICH Q10 are signaling to the world that their quality standards and procedures are high and aligned with international standards. CAPAs form one of four elements of a Q10-compliant PQS:
- A process performance and product quality monitoring system identifies existing or potential issues.
- The CAPA system takes action to understand, correct, and prevent those issues.
- A change management system ensures that any changes needed are correctly implemented.
- A management review verifies that the issues have been dealt with.
- ISO 9001:2015: The International Organization for Standardization (ISO) 9001:2015 is a globally recognized standard for quality management. It’s not specific to the pharma industry but can be applied to all sectors to help companies demonstrate their commitment to quality.
Strengthen your CAPAs with a ready-to-use root cause analysis template!
What triggers a CAPA?
Events that trigger CAPAs include:
- Warnings of noncompliance from regulators following an inspection
- Complaints from customers
- Internal or external audit findings
- Nonconformances where the drug product has failed to conform to specifications, or a process has deviated from the approved process
- Deviations where an unexpected event occurs during ongoing operations that differ from the approved processes, procedures, instructions, specifications, or established standards during manufacturing
CAPA process for pharmaceutical companies
The CAPA process within any pharma company needs to be well-defined and logically structured so that issues can be identified, and root causes understood, then remedied to prevent recurrence.
Of course, as with most things in such a heavily regulated industry like pharma, every step of the CAPA process needs to be clearly documented for regular (often surprise) inspections by regulators!
What’s more, while manufacturers are applying for a new product certification or marketing approval from regulatory bodies like the FDA or a notified body such as ISO, the CAPA process is heavily scrutinized. This shows what an important role CAPA plays in ensuring quality and safety standards.
The CAPA process can be broken down into logical steps:
- Problem identification
- Immediate action
- Problem description
- Investigations and root cause analysis
- Corrective action plan
- Implementation of corrective actions
- Verification of corrective actions
- Preventive action plan
- Implementation of preventive actions
- Effectiveness review and closeout
CAPA best practices
Keeping on top of CAPAs can be tough at times, but it’s essential, which means managing them effectively and not allowing them to pile up. Here are some best practices that can help:
Assessing risk
By employing a risk-based approach, manufacturers can prioritize CAPAs and focus on the most important issues first, such as those impacting patients, product quality, or the company overall. This can help avoid overwhelming the system when there are large numbers of CAPAs to deal with.
Streamline workflows
Many companies are still using spreadsheets or—shock horror—paper, to manage their CAPAs. If that applies to your company, you might be surprised how much mapping out CAPA action plans in specialist CAPA software can streamline your workflows through automation. Actions can be tailored so that they automatically populate with due dates, are assigned to different users, and efficiently move through the process to the finish line with less admin and with all checks and balances in place.
Set realistic timelines
Managers shouldn’t impose unrealistic deadlines to close out CAPAs. They should give enough time for a thorough root cause analysis and sustainable corrective and preventive action plans to be implemented and verified.
Centralized documentation
Housing documentation in a central depository, such as a digital CAPA management system can remove the risk of falling foul of a regulatory audit or scrambling around trying to find the relevant CAPA documentation when an inspector calls.
Cross-functional collaboration
Cross-functional collaboration can ensure that actions taken are innovative. By including team members from other functions in the company, rather than only the quality assurance team, more effective solutions can be created, and everyone is on board with the necessary updates.
Ongoing training
Regular CAPA training for employees is an essential part of ensuring the system runs efficiently. Everyone should understand the part they play in the CAPA process and be trained on how to identify issues, contribute towards root cause analysis, and implement corrective action plans.
Read up on challenges
Common challenges for implementing CAPA include inefficient root cause analysis, a lack of documentation (or not being able to locate it when needed), and manual CAPA management. Read more on our blog post “8 Common Problems with Your CAPA Process and How to Overcome Them.”
Key takeaways
- A CAPA system in pharma is a mandatory quality assurance process that identifies, addresses, and prevents issues affecting drug product quality or manufacturing processes.
- CAPAs are often triggered by warnings from regulators, customer complaints, nonconforming products or procedures, process deviations, or audit findings.
- The stages of a CAPA process include identification of an issue, investigation into its root cause, planning and implementing CAPAs, and verifying that the actions taken were effective.
- CAPAs can pile up, and manual CAPA processing with spreadsheets can be inefficient. Digital
CAPA management software allows workflows to be streamlined and provides a central documentation repository to ensure compliance with CAPA regulations.
Conclusion: CAPA in pharma made easy
The FDA, EMA and other regulatory bodies frequently highlight the shortcomings in CAPA procedures and investigations. Although a CAPA system is mandatory, its true value is in fostering continuous process improvement, enhancing the quality and safety of drugs, while helping companies build and protect a reputation for quality.
Implementing CAPAs doesn’t need to be a tedious manual process, and CAPAs don’t need to pile up. The right tools, such as a digital CAPA management system, can accelerate workflows, cut admin, and reduce the risk of non-compliance.
