Here you will find answers to the following questions:
In pharmaceutical operations, considered in the broadest sense of the term – in other words, in all GMP-regulated activities – a situation can always arise in which regulations and predefined procedures are not observed or in which procedures do not bring the best results or meet expectations. In such cases, rapid intervention is required in addition to the usual documentation, investigation, explanation and risk assessment in order to restore the balance of procedures and predefined processes (such as in the Quality Management System), to identify and eliminate potential weaknesses, or to optimise these processes to promote continuous improvement.
Examples of non-compliance with predefined procedures or inadequate processes can be:
Generally speaking, the points listed above could be summarised under the collective term non-conformity. However, for the sake of simplicity, this will be referred to hereafter as deviation. For each deviation, the top priority is to take immediate action to eliminate the root cause of the deviation and/or to prevent additional damage, e.g. to re-establish the conformity of the batch, if this is possible (Correction).
Subsequently, in most cases there are relevant corrective actions to be taken to effectively prevent recurrence of the same deviation in the same process or other processes or procedures (Corrective Action).
An additional further possible step might be the proactive evaluation – based on a risk assessment – to determine how potential similar or different deviations can be prevented in this and other processes (Preventive Action).
A corrective action therefore always refers to the previous occurrence of a failure, an error or a deviation, whose recurrence should be prevented. In contrast, a preventive action attempts to prevent a potential error in advance, using suitable techniques. In order to identify potential errors and weak points, the usual tools of risk management may be applied, like e.g. FMEA or HACCP, but also statistical process control, Six Sigma Tools and standard follow-up measures for risk reduction.
In a modern pharmaceutical quality system that complies with ICH Q10, this procedure is referred to as CAPA system (Corrective Actions and Preventive Actions). In simple terms, the CAPA system must always be applied when deviations in the process or problems with the product or the supplied service occur or potential problems are anticipated. The identification of the possible failure cause(s) (Failure Investigation or Root Cause Analysis) is an essential prerequisite, in order to determine and implement the appropriate measures.
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How to Manage Corrective and Preventive Actions (CAPA) in a GMP Environment.