CAPA Analysis: It’s Importance and Role Within Root Cause Analysis

When dealing with pharmaceutical products or medical devices, problems in the production and manufacturing process can arise. These might be major failures, complaints from customers or other sources, or issues found during a routine inspection.

If one of these failures does show up, it is necessary to conduct a root cause analysis to determine what happened, why it happened, and if it is a one-time occurrence or a problem with your current processes.



One of the most important tools an organization has is CAPA: corrective actions and preventive actions. A CAPA system is in place to help identify, document, and address any deficiencies and nonconformities found in your organization.

CAPA can be broken down into two separate systems:



• Corrective Action: When existing nonconformity is found, action is taken to eliminate the cause so that recurrence is not likely. 
• Preventive Action: To prevent occurrences of nonconformity, action is taken to identify and eliminate probable causes.

These systems can be in place in almost any industry but for industries like food processing, medical device manufacturing, and pharmaceutical development, this is a legal requirement from the FDA. 

There are two main reasons why an organization should implement a CAPA analysis system: because it is a good way to identify and rectify failures in your processes and because the FDA requires it under regulations like FDA 21 CFR 820. 

FDA’s Code of Federal Regulations Title 820 is the regulation of quality systems that requires corrective and preventive actions to be documented in medical device manufacturing. The FDA believes CAPA helps accomplish some of the following:
 

• Gathers and analyses information to help locate existing and possibly potential nonconformities
• Applies necessary corrective and/or preventive actions
• Ensures that these CAPA actions have been successful
• Communicates CAPA activities to employees and management, while documenting activities for review

CAPA should be implemented as part of a larger quality management system, whether connected to the ISO 9000 standard or other systems like the Good Manufacturing Practice (GMP).

Those in positions of manufacturing and packaging, quality assurance or quality control, and those on investigation teams dealing with Root Cause Analysis will all play a role in implementing CAPA within their processes.

To understand how to initiate, conduct, and/or manage Root Cause and CAPA investigations in a pharmaceutical, clinical manufacturing, biologics, or medical device environment, CfPIE offers the perfect course: Pharmaceutical Root Cause Analysis of Failures & Deviations - Developing an Effective CAPA Strategy.

This Root Cause Analysis training course is designed for personnel who are responsible for the failure and deviation investigation process in a GMP environment, specifically Root Cause Analysis for CAPA.

Have questions? Get in touch with a member of the CfPIE team by calling 1-610-648-7550 or emailing [email protected].

A medical combination product is any therapeutic or diagnostic product that combines pharmaceutical drugs, medical devices, and/or biological products. As technological breakthroughs advance, the FDA expects to review larger and larger numbers of these products.

As separate entities, these products would be handled by a different FDA center, depending on type: the Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), and the Center for Devices and Radiological Health (CDRH).

This creates regulatory, policy, and review challenges when a combination of devices or drugs are integrated into one product. Each component has a different regulatory pathway, and this can impact the processes needed for development, clinical trials, manufacturing, and advertising.

There are various regulatory and statutory provisions pertaining the medical combination products. FDA’s 21 CFR Part 3 and Part 4 contain most of the current regulatory rules in place.

Part 3’s regulations consist of how to classify medical products as drugs, devices, biological products, or combination products. This is where you will find the definition of a medical combination product or device and the requirements for the Request for Designation (RFD).

In Part 4, the regulations listed cover the current good manufacturing practices for medical combination products. It also lists the requirements for post-market safety reporting for these devices. 

When planning the development, manufacturing, and desired pathway to market for your product, each decision can impact what the specific regulation of the product will look like. This complexity is why staying in contact with the Office of Combination Products (OCP) throughout the whole process is necessary.

Because of the difficulties surrounding medical combination products and their respective FDA centers, the FDA has numerous online sources for every step of the process. These sources cover jurisdictional, pre-market, and post-market situations. 



Some of the circumstances explained in the online sources are:

• How to write and prepare a pre-request for designation and request for designation (Pre-RFD and RFD).
• Requesting FDA’s feedback on medical combination products. 
• The early development considerations for combination products. 
• The current good manufacturing practice requirements. 
• The post-market safety reporting for combination products. 
• How to submit a request for post-approval modifications to a combination product previously approved under a BLA, NDA, or PMA.
  

For the professionals dealing with medical devices and products and who need a firm understanding of the complexities of regulation and approval of combination products, CfPIE offers the course Introduction to Medical Combination Products.

This course will cover the current FDA regulations in regards to developing and marketing combination products. Any of those dealing with product development, manufacturing, quality assurance, and/or regulatory affairs around medical combination products will benefit from this course.

Have questions? Get in touch with a member of the CfPIE team by calling 1-610-648-7550 or emailing [email protected].