What is a CAPA?
A Corrective and Preventive Action (CAPA) is taken to correct existing (corrective) or potential (preventive) deviations occuring or reoccuring in all and any areas of Good Distribution Practice compliance and procedures. If done correctly this will reduce or eliminate any risks they would cause.
A deviation is defined as an “action of departing from an established course or accepted standard“.
To successfully correct/prevent a deviation, the root cause(s) must be found so that the CAPA directly addresses and resolves the problem. You will need to carry out an assessment and evaluation of any possible consequences of the action to see the impact it may have on all areas of Good Distribution Practice operations, whether that be positive or negative. For the action to be implemented the benefits must outweigh any risks and there must be no serious risk to the safety of patients.
If CAPAs aren’t implemented correctly it could lead to further deviations/failures which may impact the integrity of the products and pose a risk to patient safety.
A short while after the action has been performed there should be an evaluation of its effectiveness as well as any impacts it has had on other areas of operation. If it has not been as effective as planned the process will need to be carried out again. If it is causing further deviations it must be resolved immediately to prevent risks.
The RP will need to be informed of ALL deviations and CAPAs.
Training will be needed on both CAPAs and deviations to ensure that the process is as successful as possible and that all problems can be identified quickly. It will be the responsibility of the RP to make a training plan for each department and keep all records of this, including the plan itself and any evidence of training (e.g. tests and certificates).
Further Assistance and Support
If you require training, check out our online courses or our training calendar via the buttons below for the training courses we run monthly on the whole of the GDP EU Guidelines.
If your need assistance with implementing CAPAs or finding existing/potential deviations, get in touch with us via the contact form below and we can arrange a consultation.
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