CAPA Records: What’s the Right Balance?

Q: How much CAPA data do I need to support opening a corrective and preventive action investigation?


A: This is an interesting question because it raises the issue of whether a company is overusing or underusing the CAPA system. One data point is enough to open a CAPA depending on whether that data point is a significant occurrence. On the other hand, multiple similar deviations may be overlooked because they are deemed minor with little impact on operations. The most effective way to determine whether you should open a CAPA is to perform a risk assessment of the data.


Preventative Action


regulatory compliance

A single significant deviation, such as putting the wrong label on the product, should justify opening a CAPA. This type of production error carries a high risk and should consider preventative action Sops. If the mislabeled product is released with the incorrect label, it creates a serious risk to patient safety. The CAPA is necessary because it will enable the company to determine the appropriate actions needed to prevent the issue for recurring.


CAPA Manufacturing


In addition, the CAPA will prompt the company to review quality data across manufacturing lines and manufacturing facilities. This type of CAPA quality corrective solution to prevent recurrence can be implemented across the company. An example of a single CAPA records data point that does not necessarily need a CAPA opened might be a field complaint of a bottle of tablets that contained 99 instead of 100 tablets.


CAPA Quality


This occurrence should be investigated, but because it is low risk and more of an inconvenience to the patient, it may not require a CAPA. Opening a CAPA for this one event could be considered overusing the CAPA system. That being said, if the complaint department tracks these data and finds a significant upward trend of short count bottles over a short period of time, a CAPA may be warranted.


CAPA Corrective Action


Underusing the CAPA system is also a concern. Not considering corrective action when faced with CAPA records that suggests there is multiple occurrences of the same/similar deviation prevents the company from continuously improving processes. Let’s suppose that in reviewing deviations you notice that a few manufacturing employees have multiple deviations for the same minor issue in the same batch record over a short period of time and that the deviation has been determined to be human error and only retraining of the operators was performed.


CAPA Quality Assurance


In this scenario, it would be prudent to open a CAPA for several quality assurance reasons. First, human error is rarely the cause of a deviation. Second, obviously the retraining to prevent the error is not effective because the error keeps occurring. Third, the data are telling you that you may have an issue in how effective your process for investigating deviations is being implemented.


CAPA Audit





There is no hard and fast rule on how much data you need to open a CAPA. It could be one data point or several data points. The best tools to use to determine whether a CAPA is needed is a risk assessment of the data and common sense.









Pharmaceutical Technology

Vol. 47, No. 4
Page: 50


About RCA’s Pharmaceutical Consulting Services 


Regulatory Compliance Associates (RCA) has helped thousands of pharmaceutical companies meet regulatory, compliance, quality assurance, and remediation challenges. With more than 20 years of experience with FDA, Health Canada, EU and global regulatory agencies worldwide, Regulatory Compliance Associates® offers leading pharmaceutical consultants. We’re one of the few pharma consulting companies that can help you navigate the challenges associated with industry regulations.


Our pharmaceutical consulting firm includes over 500 seasoned FDA, Health Canada & EU compliance consultants and regulatory affairs experts who understand industry complexities. It’s a pharma consultancy founded by regulatory compliance executives from the pharmaceutical industry. Every pharmaceutical industry consultant on the Regulatory Compliance Associates team knows the unique inner workings of the regulatory process. 


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As your partner, we can negotiate the potential assessment minefield of regulatory compliance services with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and regulatory compliance consulting. We offer the following pharma consulting regulatory affairs services for pharmaceutical companies.


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The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand. Just one misstep could mean significant and lasting consequences for your business. At Regulatory Compliance Associates, we offer the pharma consulting experience and pharma consultants necessary to guide you through the quality compliance process.


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In addition, each Regulatory Compliance Associates pharma consulting Expert understands compliance enforcement. We’ll prepare a comprehensive pharma consulting strategy to assist in your remediation efforts, drive continuous improvement, and maintain regulatory compliance with the regulations.


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About Regulatory Compliance Associates


pharmaceutical consultantsRegulatory Compliance Associates® (RCA) provides pharmaceutical consulting to the following industries for resolution of life science challenges:



We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.


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About Sotera Health


The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.


Sotera Health Company, along with its three best-in-class businesses – Sterigenics®Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.


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