Principally, a CAPA system can be implemented in a pharmaceutical company using two different approaches (see below). Regardless of the selected organizational structure, it should be ensured that the CAPA system is understood as an important element of the pharmaceutical quality system and consequently be implemented uniformly company-wide or group-wide, as a governing system.
An independent CAPA system is characterised by its own documentation and schedule tracking. In an independent CAPA SOP, the procedures for the definition, responsibility, schedule tracking, and closing of CAPA activities are described. These are derived as possible follow-up activities from incidences that are regulated in other systems (deviations, complaints, self-inspections, Six Sigma, etc.). Triggered, for example, by a deviation (broadly defined) and the following risk assessment – if necessary – a subsequent CAPA process is started in the independent CAPA system and tracked using an own documentation system. Important, therefore, is the clear and comprehensible connection of the two processes.
The advantage of this system is a clear separation between the different procedures (e.g. deviation – CAPA) with regard to execution and documentation. Each system can then be monitored, presented, and discussed separately and individually.
However, this advantage is inseparably associated with a substantial disadvantage, as the two separate procedures must reference one another in order to allow clear tracking and trending. There is a risk that information might be lost or incorrectly transferred. Only when both documentation systems are taken together are they clearly legible and comprehensible for the CAPA system.
A further disadvantage is that similar or re-occurring incidents and actions, that might be considered non critical when assessed separately, may turn out to indicate systematic problems or system weaknesses when viewed comprehensively, something that may not be recognised when assessed independently.
Modern IT systems, however, are capable of generating the appropriate specific procedures for different activities that are clearly linked with one another, making all relevant information easily accessible.
A further benefit of a separated system is that immediate measures and prompt corrections taken to address and if possible to eliminate the deviation may still be documented and processed within the “triggering” system, thus avoiding the inflationary generation of CAPA processes.
A more convenient way of establishing a CAPA system is to specify relevant CAPA procedures within the triggering system. In that case, the documentation form of the initial incidence (e.g. a deviation) would, following a risk assessment, document also the defined corrective actions as well as the implementation and the final efficacy check. After closing of both the initial incidence or problem and the specified CAPA activities, the responsible quality unit can easily evaluate and track both interlinked processes.
For this purpose, after the entire process has been finished, it must be transferred back to the quality unit for statistical evaluation (trend analysis, management review, etc.) and closing in the Quality Management System. Should there be concerns on the part of the quality unit, the system must grant the quality unit a right to reject. In this case, the procedure will be transferred back to the responsible unit, in order to achieve an acceptable conclusion.
In order to fully understand the system of corrective and preventive actions and its growing significance, it must be seen within the context of the sequence of different, discrete processes (deviations – root cause investigation – risk assessment – CAPA – trend analysis – management review). It is situated at the end of the process chain of quality systems, which are linked together in a governing Quality Management System ranging from the detection of an incidence, failure, error or (potential) problem to the following investigation and approval, further to the definition of activities to prevent recurrence, and the efficacy check.
This text is an excerpt from the GMP Series How to Manage Corrective and Preventive Actions (CAPA) in a GMP Environment
How to Manage Corrective and Preventive Actions (CAPA) in a GMP Environment is the ultimate guide on building and implementing an effective CAPA compliance program. The pdf download shows how you can establish an effective CAPA system, which interfaces there are to other systems and what content a CAPA SOP should have.
Here’s an overview of what you’ll discover in its pages:
Dr. Bernd Renger
Bernd Renger Consulting