Deviation is a departure from a documented or standard procedure or process. To comply with GMP and for continuous improvement deviation handling is required. That’s why deviations are recorded in real time, investigated with root cause analysis and corrective and preventative actions are implemented to close this.
In pharmaceutical industry, deviation handling is an essential element of a well-established Quality Management System (QMS), which plays a key role in assuring quality in products and by contributing to continuous improvement.
As part of a comprehensive deviation handling program, once a deviation is detected, it needs to be taken immediate actions, then the root causes identified as necessary, and systemic actions to be implemented (i.e., corrective actions) as applicable in order to prevent future same or similar non conformances (i.e., preventive actions).
The process flow of deviation handling –
- Event Detection
- Deviation Categorization (Major/Minor, Planned/Unplanned)
- QRM initiation
- Root cause investigation
- CAPA
Event Detection
The event detection is largely depends on their level of training, qualification, expertise, commitment, and support form upper management.
Deviation Categorization
During deviation handling a decision needs to be made to categorize the deviation as Minor, Major or Critical. The decision tree for deviation characterization is given in Diagram 1(As per Draft guideline of ICH) -
QRM initiation
QRM is also to be initiated for deviation handling. 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.
Root cause investigation
Root Cause Investigation is an essential part of deviation handling and this tool also used for quality improvement. Among the different tools available for Root Cause Investigation, the “5 Whys” and “Ishikawa Fish Bone Diagram” are the simplest and most used ones.The root cause investigation process is also a key step in handling major and critical deviations as it will provide objective evidence to implement corrective and possibly preventive actions as part of the CAPA system.
Corrective and Preventive Actions (CAPA)
Corrective and preventive actions (CAPAs) are a very important part of pharmaceutical quality systems to improve the product and process robustness.
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. Corrective actions could be transferred to an independent CAPA system to avoid unnecessary delay for deviation closure.
In addition, manufacturers are strongly recommended to identify preventive actions which are proactive in nature and prevent the recurrence of the problem (preventative actions).
There should be a written procedure for deviation investigation timeline and deviation closing timeline. Which will help an organization to reduce the deviation frequency and quantity.