Incident Investigation Reporting is an important aspect of the Pharmaceutical Industry. Herein are the brief details of “Incidents/ Deviations, reporting, Investigation, Correction, Corrective Action and Preventive Actions, and Closure” discussed below. Hence, please refer to this useful Whenever any incident occurs or is observed, the observer shall report the incident immediately. The observer together with the department head (or designee) shall evaluate the impact of the incident on the Quality/ Purity/ Identity/ Strength of the product. Based on the evaluation, the incident shall be classified as Quality Impacting or Quality Non-Impacting. The observation shall be documented by using Incident Investigation Report. The observer shall address the incident by filling out the relevant information form (Incident Investigation Report format). Determine the impact of the incident on Batch/Batches in process. Record the details of the immediate action to take for the batch affected. The same shall be intimate to the concerned department HOD and QA. The observer shall perform the risk assessment for each Quality- Impacting incident and the same shall attach and forwarded to the respective HOD and QA. HOD has to ensure completeness of impact and risk assessment checklist while HOD comments in Incident format. QA shall review the incident for its completeness and comments in Incident form & assign investigation and conclusion & QA review and comments task for further detailed investigation. The respective HOD or designee shall carry out a detailed investigation immediately after the occurrence of the incident. The five generic causes – Material, method, personnel, equipment, and environment shall consider identifying the root cause. Based on a review of available information and data, assess the probable cause and summarize to conclude and identify the root cause. Based on the investigation, evaluation, and conclusion, the observer/concerned HOD or designee shall perform the recommended actions for the affected Bach/batches. If any incident is associated with a batch then the recommended corrective action must complete before releasing the batch. The observer/concerned HOD shall mention the CAPA with a timeline to avoid the recurrence of the incident. After a complete investigation, QA shall review and assign the CAPA to the concerned persons with timelines. For incidents associated with the products that are released by QP arrange to intimate the QP. After investigation and conclusion if it reveals that the incident occurred due to input raw material quality, particularly raw material vendor details shall be entered by QA in the incident format before the closing of the incident. All incident reports shall investigate within 15 working days unless any extensions shall be justified. Delays in CAPA shall be justified with new timelines by the concerned person. QA shall review the justification and approve the new timeline. Plant QA in charge shall monitor the CAPA and ensure compliance with recommended CAPA. Quality Assurance (QA) shall review monthly to ensure the timely closing of CAPA. A review of the incidents shall carry out on a tri-monthly basis and presented to senior management. The observer shall address the incident by filling in the relevant information format (Incident Investigation Report) and intimating it to the respective department HOD and QA. HOD to ensure completeness while giving comments in format. QA shall review the incident for its completeness and comments in format & assign investigation and conclusion, CAPA, Review by HOD & QA review and comments task for further detailed investigation. During the review, if it is revealed that the impact of the incident is Quality Impacting, the incident is to be handled as per the Quality Impacting incident procedure. The incident investigation must aim at the identification of the root cause. The observer and HOD to carry out an incident investigation. All Quality Non-Impacting incidents shall forward to QA for review within 7 working days of occurrence. After taking CAPA (Corrective Actions and Preventive Actions), concern HOD to review & dispose of the report Individual action plans to track through CA-PA to ensure completion within timelines. A review of the incident investigation shall carry out on a tri-monthly basis and presented to seniors. Incident report preparation is the responsibility of the concerned department. Ex: 200000001 The Incident investigation report shall flow in listing possible root causes. The investigation must evaluate the impact of the incidents on the other batches/products/ areas. The report shall be written/typed in clear terms and simple sentences. All investigations must summarize the root cause / possible root cause identified with the necessary CAPA. The incident report shall file with the concerned department & WITH QA. If the raw material/ packing materials are rejected. An online rejection note shall raise by the initiator department after approval from the QA department. The same shall attach to the incident report. Impact assessment and Risk Assessment must be part of the Incident investigation. Along with the logging of an incident, the initiator has to perform the Risk assessment for each Quality impacting incident, and the same is to be attached and forwarded to the concerned HOD. The concerned HOD has to ensure the completeness of the impact and a risk assessment checklist. In case of network failure, conceptual approval shall take from the respective HOD/ Designee and the details shall be recorded manually in format. The notification shall approve by relevant departments and QA shall approve the incident. The same incident shall upload in the system for numbering and for further activities. Refer never before pharma articles only at PharmaeliX – OOS SOP Latest Guidance 2023
Incident Investigation Reporting Procedure
Handling of Quality Impacting incidents
Incident Investigation Reporting and Conclusion
Handling of Quality Non-Impacting incident
Incident Investigation – Numbering System
Incident Investigation Reporting and Documentation
Impact assessment and Risk Assessment
Notification Approval by Manual process
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