CAPAs stand for corrective and preventive actions. It can be defined as a systematic approach to investigating an unfavorable occurrence with an aim of identifying the root cause and reducing the future occurrence of the root cause by planning actions to either correct or prevent it. It is an important element of any Quality Management System that helps in continuous improvement of manufacturing processes by systematic investigation of deviations, complaints, and non-compliance occurrences.
As per ICH Q10, a pharmaceutical company should have a system for implementing corrective actions and preventive actions resulting from the investigation of complaints, product rejections, nonconformities, recalls, deviations, audits, regulatory inspections and findings, and trends from process performance and product quality monitoring. A structured approach to the investigation process should be used with the objective of determining the root cause. The level of effort, formality, and documentation of the investigation should be commensurate with the level of risk, in line with ICH Q9. CAPA methodology should result in product and process improvements and enhanced product and process understanding.
As per FDA 21 CFR 820.100 following are the requirements that food and drug manufacturers are required to meet:
A. Each manufacturer is required to establish and maintain procedures for implementing corrective and preventive action. The procedures shall include requirements for:
- Analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned products, and other sources of quality data to identify existing and potential causes of nonconforming products, or other quality problems. Appropriate statistical methodology shall be employed where necessary to detect recurring quality problems;
- Investigating the cause of nonconformities relating to the product, processes, and the quality system;
- Identifying the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems;
- Verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device;
- Implementing and recording changes in methods and procedures needed to correct and prevent identified quality problems;
- Ensuring that information related to quality problems or nonconforming products is disseminated to those directly responsible for assuring the quality of such product or the prevention of such problems; and
- Submitting relevant information on identified quality problems, as well as corrective and preventive actions, for management review.
B. Document all activities required under 21 CFR 820.100, and their results.