SOP FOR INCIDENCE HANDLING
PURPOSE: To lay down a procedure for reporting, investigation and disposition of Incidents.
SCOPE: this procedure is applicable to the reporting of investigation and disposition of unplanned, uncontrolled incidents either directly or indirectly associated with Manufacturing/Packaging, or Analytical operations.
RESPONSIBILITY: Observer / Concerned Department Officer shall report the Incident.
Observer / Concern HOD or designee shall investigate and conclude the Incident with Corrective and Preventive Action(s).
Concerned HOD or designee shall evaluate, dispose the Quality Non-Impacting Incident and forward to Head QA for review.
Head QA or designee shall evaluate, dispose the Quality Impacting Incident and ensure the compliance of agreed corrective and preventive action.
Head QA is responsible for implementation and compliance of this procedure.
ACCOUNTABILITY: Head QA shall be accountable for this SOP.
PROCEDURE:
Definition
Incident: An incident is defined as unplanned or uncontrolled event in the form of non-compliance to the designed systems or procedures at any stage of manufacturing, packaging, testing, holding and storage of drug product due to system failure or equipment breakdown or manual error.
The incidents are of two types: Quality Impacting Incident or Quality Non-Impacting Incidents.
Quality Impacting Incidents:
Those occurrences / errors reported during execution of activity, which may affect the Quality, Purity, and Strength of the drug product or documents. Examples of Quality Impacting Incidents are listed.
Quality Non-impacting Incidents:
Those occurrences / errors reported during execution of activity, which may have no impact on the quality, purity and strength of a drug product. Examples of Quality Non-impacting incidents are listed as per Format No: SOP.
Whenever any incident occurs or is identified, the identifier together with the department head or designee shall evaluate the impact of the incident on the Quality, Purity and Strength of the Product.
Based on the evaluation, the incident shall be classified as Quality Impacting (if it is directly impacts the Quality / Purity / Strength of the product) or Quality Non-Impacting.
Handling of Quality Impacting Incident:
The identifier shall address the incident by filling the relevant information (Specific details like Batch number, date of occurrence, when noticed, Stage of processing, etc.), determine the impact of the incident on the batch / batches in progress, (where necessary isolate the affected lot/batch). Record the details of the immediate action to be taken for the batch affected. In addition, it shall be intimated to concern department HOD and QA.
Handling of Quality Non-impacting Incident:
The identifier shall address the incident by filling the relevant information (Specific details like Batch number, date of occurrence, when noticed, Stage of processing, etc.) and it shall be intimated to concern department HOD and QA.
The identifier and the concerned Head of Department or designee shall carry out the detailed investigation. The investigation must be aimed at identifying the root cause / possible root cause.
All operations /analysis/ documents which give the information about the cause of the incident shall be investigated.
The details of investigation, conclusion shall be recorded by observer / concerned HOD/Designee.
Based on the investigation, concerned HOD or designee shall mention the corrective and preventive action (s) to avoid the recurrence of the incident.
After taking corrective and Preventive actions, the Incident Report shall be disposed by concerned department head or designee.
All Quality Non-Impacting Incidents shall be forwarded after investigation and conclusion to QA for review within 7 working days of occurrence.
During the review, if it is revealed that impact of incident is Quality Impacting, the incident shall be handled.
Numbering of Quality Impacting /Non-Quality Impacting Incident
The Quality Assurance Department assigns tracking number to incident as follows
Incident Number: AB/YY-NNN
Where AB stands for QI or NQ, (i.e.) QI indicates Quality Impacting and NQ indicate Non-
Quality Impacting Incident.
“/” denote the separation.
YY stands for last two-digit year
“-” denote the separation
NNN stands for the continuous serial (E.g: 001,002……..)
Quality Assurance shall maintain an “Incident Register” with details as described.
Investigation and conclusion:
Concerned HOD or designee shall carry out detailed investigation immediately after the occurrence of the incident. The investigation must be aimed at identification of the root cause or probable root cause.
All operations/documents which give information about the cause of the incident shall be investigated.
Based on review of available information and data, assess and identify the probable causes which may be reason of incident.
Evaluate the probable causes and summarize to conclude and identify the root cause. Where necessary, any additional testing/simulation study may be carried out to confirm the root cause.
During investigation and conclusion of an incident, assistance of other department(s) shall be sought, as appropriate.
The details of investigation, conclusion shall be recorded by observer / concerned HOD/Designee.
Based on the investigation, evaluation and conclusion, observer / concerned HOD or designee shall perform the recommended actions for the affected batch / batches.
It shall be ensured that, if any incident is associated with a batch then the recommended corrective action must be completed before release of that batch.
Observer /concerned HOD or his designee shall mention the corrective and preventive action (s) with a time line for completion to avoid the recurrence of the incident.
After complete investigation and conclusion of incident, QA shall review and assign the Corrective and Preventive actions (if any) to the concerned persons with timelines.
For incidents associated with products that are released by Head QA with details of the incident.
All incident report shall be investigated within 15 working days, unless any extensions shall be justified.
In case the CAPA is not completed within assigned time lines, concern person shall provide the justification for not completion of CAPA Plan with new timelines.
QA shall review the justification and approve the new timeline for CAPA Plan.
Head QA or designee shall monitor the Corrective and Preventive action and ensure the compliance as mentioned in CAPA plan.
Quality Impacting Incidents shall be reviewed monthly to ensure timely closure of CAPA. A review of the incidents shall be carried out on a tri-monthly basis with analysis of repetitive nature of incidents and CAPA taken and presented to Senior Management. The review shall indicate if any further action needs to be taken to ensure that repetitive incidents are avoided.
Documentation:
The investigation report shall flow in a logical sequence listing possible root causes and elimination / further probe of same with adequate support data. The investigation must evaluate the impact of the incident on other batches / products / areas etc. wherever applicable.
The investigation report shall be written / typed in clear unambiguous terms and simple sentences.
Additional documents if used shall be annexed to the incident with proper tracking and cross references.
All investigations must summarize the root cause / possible root cause identified with the necessary Corrective and Preventive Actions.
The incident report shall be filed in QA Department.
REFERENCE:
SOP FOR SOP