Deviation management in pharmaceutical industry (Deviation Handling):

Deviation management or Deviation handling consider following step :

1. Event Detection
2. Decision Making Process / Deviation Categorization
3. Deviation Treatment
4. Root cause investigation
5. CAPA 

Event Detection:
When any activity or operation performed without following the established and detected by the any person it should be identified and documented. personnel shall aware of possible undesirable events and clearly know what to do in terms of documenting and communicating them.

Decision Making Process / Deviation Categorization:
After Identifying the undesirable event person shall know that what activity shall be performed  The way personnel react and make decisions can be systemized and improved by the use of a decision tree to initially screen events based on their risk and impact on the product in order to categorize, record, and investigate them as needed.

Deviation Treatment
A pre-existent QRM will contribute to determine the categorization of the deviation. If QRM has not been performed, it may be carried out at this time as part of the impact assessment in order to determine the criticality of the process parameters involved, and the risk to the patient.
On the bases of criticality deviations can be categorized as
Minor Deviation
Major Deviation
Critical Deviation 

Root cause analysis:
Root cause analysis shall be performed to find out the why this undesirable event occur by using different tools. Most probably route cause analysis key step in handling major and critical deviations as it will provide objective evidence to implement CAPA.

CAPA:
Corrective Actions are taken to eliminate the root causes of deviations, and should be based on good quality investigations. Corrective actions should be QA approved before implemented and their efficacy verified in a documented manner, activity that could require a significant period of time. Corrective actions could be transferred to an independent CAPA system to avoid unnecessary delay for deviation closure.

Closure OF Deviation:
After completion of all action deviation shall be closed with proper action taken and training if training required.

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