When initiate a CAPA based on Statutory & Regulatory Requirements.

CAPA Statutory & Regulatory Requirements


In this article, you will learn the CAPA statutory and regulatory requirements, and when a CAPA must be initiated according to 21 CFR Part 820.100.

Whenever a non-conformance is observed in violation of the current cGMP requirements and product specifications, maybe a market complaint or customer complaint or failure of machinery or a quality management system, or misinterpretation of written instructions to carry out work, or any other discrepancy. The corrective and preventive action is designed by a team that includes quality assurance personnel and personnel involved in the actual observation point of nonconformance.

It must be systematically implemented and observed for its ability to eliminate further recurrence of such non-conformance, including its effectiveness.


The Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations describes the CAPA importance in the following reference: httpss://www.fda.gov/media/71023/download

 Also, the following quality system regulation describes the CAPA requirements:


Subpart J–Corrective and Preventive Action

Sec. 820.100 Corrective and preventive action.

(a) Each manufacturer shall establish and maintain procedures for implementing corrective and preventive action. The procedures shall include requirements for:

(1) Analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems. The appropriate statistical methodology shall be employed where necessary to detect recurring quality problems;

(2) Investigating the cause of nonconformities relating to the product, processes, and the quality system;

(3) Identifying the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems;

(4) Verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device;

(5) Implementing and recording changes in methods and procedures needed to correct and prevent identified quality problems;

(6) Ensuring that information related to quality problems or nonconforming product is disseminated to those directly responsible for assuring the quality of such product or the prevention of such problems; and

(7) Submitting relevant information on identified quality problems, as well as corrective and preventive actions, for management review.

(b) All activities required under this section, and their results, shall be documented.

Consequences to not initiate or not perform an adequate CAPA investigation?

Failure to adhere to proper CAPA handling is considered a violation of US Federal regulations on good manufacturing practices. As a consequence, medicine or medical device can be termed as adulterated or substandard if the company has failed to investigate, record, and analyze the root cause of a non-conformance, and failed to design and implement an effective CAPA.  In some cases, it may result in an FDA warning observation, product hold, product recall, etc.

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Need CAPA Training

CIQA is a quality and regulatory consultant with 25 years of experience developing products and managing projects in the medical device supply chain, and pharmaceutical industries. His experience includes research, product development, operations management, manufacturing engineering, equipment design, regulatory affairs, and quality assurance. Specific questions about CAPA or quality system training can be directed to CIQA at ramon.cayuela@ciqa.net.

Need help & support during your CAPA activities or need templates to create a CAPA procedure, visit us,


For more details on specific FDA expectations and how to create CAPA documents necessary, follow us.

Quality procedures templates

Three (3) Options to Create CAPA Procedures:

Bronze Option. You Can Create Your Own Quality Procedures, using a Template.

You can download samples of the CAPA procedure templates in .pdf format. 

To see the complete list of the most popular quality procedures templates, click here.

In addition, you can request a quotation to buy online a full SOP template document in MS Word format that is completely editable, ready to fill and adapt to your specific needs.

Silver Option. We Can Bring You a Formal Training on how to prepare a CAPA Investigation?

This option is recommended if you want to learn more about how to build robust quality system procedures. One of our expert(s) can provide online step-by-step training to your team (unlimited assistance) on how to build reliable SOPs using our template(s). Also, you can improve your corporate quality procedures and policies by incorporating our template(s) and tools.  It includes a fully editable template from the Bronze option, plus training, exams, and a training certificate for each assistant.  Request a quote now.

Gold Option. We Can Create Customized Quality Procedures.

One of our expert(s) will create and prepare your customized SOPs with the inputs and specific information of your company. It includes a fully editable template from the Bronze option, plus online support in document creation, implementation, and training. Request a quote online.



For more information about CAPA, refer to:




Picture of Ramon Cayuela, MS, BS, Chemical Engineering

Ramon Cayuela, MS, BS, Chemical Engineering

CIQA President and CEO.
I've been working in validation engineering since 1992 with many multinational pharmaceutical companies. I love sharing my passion and knowledge with others. If you have any questions about anything (or just have general questions). I will be more than happy to assist you. You can count on the BEST customer service on CIQA. I go to great lengths to make sure my clients are 100% satisfied with their purchases and check emails/messages consistently throughout the day. You can rest assured that everything being sold here is as-described or your money back. I look forward to working with you!