Corrective and preventive actions (CAPA)

In the environment of good pharmaceutical practice, the manufacturer must have a system of management and control of corrective and preventive actions (CAPA). The investigation carried out during a claim, refusal, non-compliance, recall, deviation, audit and inspection discrepancy, as well as trends observed by the performance monitoring system of the process and quality of the product, are part of a structured process to determine the root causes. This process of investigation of the CAPAs is commensurate with the level of quality risk introduced by the non-compliance or the need to increase reliability, and aims to improve the manufacturer’s knowledge and understanding of the product and the processes.

When a situation deviates from predefined procedures or when the documentation does not provide the best result or does not meet expectations, prompt action is needed to restore the balance, identify and eliminate potential weaknesses, or to optimize the processes in order to promote continuous 

According to ICH Q10, when an action aims to eliminate a detected nonconformity or undesirable situation, it is a corrective action to prevent them from reoccurring. When the nonconformity or undesirable situation is potential, a preventive action must prevent them from occurring.

Management of corrective and preventive actions (CAPA) at Seratec is based on this modern approach. Seratec has established a CAPA system that is always applied when deviations occur in the processes or there are problems with the product or services provided by a third party. And because the CAPA system must not only focus on exceptions, the CAPA system is especially implemented when potential problems are anticipated, such as the result of a preliminary risk analysis of a system, a process or a procedure. Seratec identifies the possible cause leading to failure through a failure investigation or analysis of causes, an essential prerequisite, in order to determine and implement appropriate measures to restore the balance. Our CAPA methodology thus allows us improve our products, processes and procedures and to develop a better understanding of them.

Seratec thus implements a system of corrective and preventive actions throughout the product life cycle. This is iteratively the case during development, and during the transfer of the procedure in production and during commercial manufacturing, and this approach and the information obtained also apply to products of the same family and continue until they disappear from the market.

This approach is a true profession of faith, which the pharmaceutical industry must apply to protect the patient and commensurately with each of the risks incurred. It is opposed to other industries that could, with such a CAPA system, offer us over time more efficient and cheaper phones or means of transportation that are energy efficient, that is to say to fight planned obsolescence.