Corrective And Preventive Action

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Corrective and Preventive Action (CAPA) (" Corrective and Preventive Action ") is a process from the Quality Management System ( QMS ). This is part of GMP-compliant work ( Good Manufacturing Practice ). Any discrepancies / deviations / errors that occur are systematically investigated and corrective action and then preventive action are carried out. In contrast to other quality management standards such as B. ISO 9001, CAPA - as described in the ISO 13485 standard for the medical device environment - is primarily not about a continuous improvement process in the sense of ever better products, but about eliminating the deviation from requirements based on the relevant legal and technical regulations Drug and medical device safety standards.

history

The system of corrective and preventive measures was originally not defined in the EU GMP guide. However, elements of a CAPA system were also used before that, even if they were not referred to as CAPA. The term “CAPA” originally comes from the medical device regulations. The actual system element was described in DIN EN ISO 9001, ISO 13485 and FDA 21 CFR 820. The Global Harmonization Task Force (GHTF) harmonized the individual elements and further guidelines for this quality assurance system.

The CAPA principle was first introduced in 2006 when it was included in the FDA's “Quality System Guidance” . The CAPA principle has been an element of the QMS since 2008, based on the ICH guideline Q10 Pharmaceutical Quality Systems. In 2011 this guideline was included in the newly created 3rd part of the EU GMP guideline. A proprietary CAPA system is not mandatory for a pharmaceutical manufacturer, but since parts of the guideline have been integrated into other chapters of the EU GMP guidelines, these are binding for the company.

function

Corrective and Preventive Action (CAPA) is a quality management process. This process follows the investigation of the error. Often, precautionary measures or immediate corrections have to be initiated before the examination in order to avoid extended effects of the error ("Immediate Actions" or "Corrections"). The latter are not yet a CAPA.

The task of the CAPA process is to systematically remedy investigated errors or deviations for which a reason has been found using suitable measures (corrective action) or to avoid them in the future (preventive actions).

The CAPA process can be used in all areas of a company and is part of the overall quality management. These measures that are taken and carried out in an organization at the production, documentation, process or system level in order to remedy the cause of the non-fulfillment determined after the systematic evaluation and analysis and to be avoided in the future.

The implementation / recording of the corrective and preventive measures is usually drafted including by the quality assurance staff and the employees directly on site at the observation centers. In order to be able to correct or eliminate deviations, they must first be recognized and systematically recorded. Our own controls of the product (analyzes, internal audits ), observations by employees and complaints from customers, product and process monitoring through statistical process control all contribute to this . This allows you to discover errors in the process and initiate suitable measures. Not every deviation needs to be corrected immediately.

Corrective Action

In the event of any deviation, measures must be taken to avoid and correct further errors. This can be used to restore the conformity of the batch - if possible. A corrective action has been taken which is the first part of the CAPA system.

Examples of corrective measures would be:

  • Installation of test measures during (in-process controls) or after a process
  • Visible or audible alarms
  • Process redesign
  • Product redesign
  • Material handling or storage improvements

These measures can only be used to avoid errors that have already occurred. It does not capture any possible risks for errors and deviations. The data is only based on events that actually occurred.

Preventive action

The aim here is to avoid mistakes before they even arise. No errors are evaluated and improved, but the process itself is designed and optimized in such a way that fewer deviations can occur.

Examples of preventive methods:

  • the choice of another material or other components
  • Value range check of input values
  • Restriction of the purpose of use
  • Re-design of a product
  • Training of employees

If the process has already been optimized before use in such a way that sources of error are minimized, few errors can be expected in the end product. For processes that are already in use, risk assessments can be used to calculate any errors that may occur. Statistical process controls or Six Sigma tools also help to calculate possible problems and their probability. On the basis of the results, measures can be taken to improve and optimize the process and thus reduce or even cancel the calculated risks. Preventive action can no longer be taken if a problem has already occurred. If you want to ensure after a problem that it does not recur, this is corrective action, although both want to avoid future errors.

The effectiveness of a CAPA must be checked (effectiveness check). This ensures that the originally identified error has been corrected. If the CAPA is judged to be ineffective or only partially effective, further CAPAs must be drawn up. This is decided by the QA.

Pharmaceutical Industry

CAPA is part of GMP and GAMP ( Good Automated Manufacturing Practice ), a standard guide for the validation of computerized systems in the pharmaceutical industry. Thus, as part of GAMP, CAPA is a quality assurance method in the pharmaceutical industry. Medical devices and pharmaceuticals must establish CAPA in their QMS in order to comply with FDA 21 CFR 820.100. This part can be in paper or digital form and must be proven in an FDA audit.

Deming-Shewhart cycle

CAPA is part of the Deming-Shewhart cycle , so it includes the examination for deviations, the elimination and correction of the problem that caused the deviation, the control of the success and then, if necessary, a further correction. All these aspects are also represented in the PDCA ( plan-do-check-act ) philosophy. The PDCA is based on the Deming-Shewhart cycle.

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