Thursday, January 5, 2023

Corrective and Preventive Action Explanation

Corrective and preventive Action What is corrective and preventive action: An action taken to correct any defect or problem in a system, process or product or document, is called a corrective action. 

For example, during manufacturing of a tablets, there is an issue in drying of the granules and the finally the moisture content of the finally dried granules is found on higher side, then it may be decided to dry the batch again, which is in the interest of product to enhance to quality, such actions taken to correct any discrepancy aftermarket complaint, after deviation or an incidence is called as corrective action. Corrective actions are temporary actions which are specific to the defect. 

 How to take the corrective action: Any change in the written procedure is required to be done through approval of a deviation request. Therefore, if you want to do any changes in the current procedure to eliminate the discrepancy, it is even required to be done through filing of a deviation. There is a procedure to approve the deviation, which also includes risk assessments and investigations. Risk assessment for any such action to change the process is required to be done, based on the risk factors the mitigation strategy for eliminating risk is required to be in place before the approval of such actions. 
The required change must be done through change control. 

Preventive actions: What is preventive action: An action taken to prevent reoccurrence of any defect or problem in system, process or product or document, is called as preventive action. 

Preventive actions are permanent changes therefore they are required to be done through filing and approval of a change control. In a change control, the present system and the change requested is written, describing the benefits and capability of the preventive action to prevent reoccurrence of any discrepancy for which the CAPA is taken. Both above actions together are called as corrective and preventive action it is abbreviated as CAPA In a pharmaceutical company a logbook of such a CAPA is maintained with proper numbering of the CAPA done. Corrective and preventive action implemented must be challenged to evaluate that it is effective against the problem for which it is taken. Pharma Times is journal where you will get detailed technical information.

A challenge test should pass for the effectiveness of CAPA. Once a CAPA is logged it remains open for implementation, it is required to follow the process of change control filing, procurement of instruments or anything like that, and preventive actions also required to have changes done in the documents instructions, it will take the time for implementation of the CAPA. Till the implementation of a CAPA it should be periodically reviewed by the QA head for its complete implementation and closure. 

 How to close a CAPA:? Quality assurance has to verify the documents of the implementation of a CAPA, including the BMR BPR or a Change control or the installation of the instrument with its qualification documents. All these should be attached in a file with the CAPA report, for its successful implementation, reviewed and then it is closed.

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