Reporting, Investigating, and Disposition of Incidents
To lay down a procedure for reporting, investigating, and disposition incidents in the Quality Assurance Department.
Officer-QA to raise Incident Report to allot number & due date to the Incident Report.
Officer-QA & Head-QA or his designee to investigate and take necessary corrective actions.
Head-QA to dispose of the incident.
An incident can be defined as an unplanned event that occurs in non-compliance with the designed systems or procedures at any stage of the receipt, storage, and manufacture, and analysis of a drug product.
Incidents can be classified as
(a) Quality Impacting
(b) Quality non- Impacting
Quality Impacting incidents :
Quality Impacting incidents are occurrences/errors during the execution of an activity that will affect the quality, purity, and strength of a drug product.
Calculation errors with respect to Assay and LOD values during dispensing.
A major deviation from SOPs.
The Officer, who observes the incident shall immediately inform Head-QA or his designee about the incident.
An Incident Report shall be raised by Officer-QA by briefly describing the nature of the incident in Section-I of the Incident Report (Annexure-1).
Officer-QA shall allot the number & due date, enter the details of the incident in the Incident Report register’ (Annexure-2), and forward it to Head-QA or his designee.
Each IR shall be allotted a number consisting of nine characters.
The first two characters are alphabets indicating the department code as QA.
The third character is “I” indicating “Incident”.
The next three characters are numerical in sequential order starting from 001 every year.
The seventh character is the dash ‘-‘ and the last two characters are numerical indicating year. For e.g.: QAI001-23 shall be the first Incident Report in the Quality Assurance department in the year 2023.
All the investigations and disposition shall be normally completed within fifteen (15) working days from the date the incident was observed. However, if the nature of the incident is such that it requires more than 15 working days, the same shall be justified by Head-QA.
The reference number of the Incident Report shall be mentioned on the document where the incident occurred, whenever applicable.
Head-QA or his designee along with the concerned Officer-QA shall investigate the reasons for the incident. Head-QA or his designee shall describe the findings of the investigation and conclusion in Section II of the Incident Report.
Head-QA or his designee along with Officer-QA shall take the necessary actions to correct the incident that occurred and the same shall be mentioned in Section III of the Incident Report.
Depending upon the nature of the incident Head-QA may refer to Head-Production or the Divisional Head for corrective measures and mention the same in Section -III of the Incident Report.
After the investigation is complete and corrective actions are taken, Head-QA shall review & dispose of the incident by giving his comments in Section IV and forward the Incident Report to Officer-QA.
If either investigation is incomplete or corrective actions taken are inadequate, Head-QA shall suggest a further course of action. Once the suggested action is complete, he shall dispose of the incident.
Officer-QA shall enter the disposition date of the incident in the ” Incident Report Register” and fill the Incident Report in the ” File for Incident Reports – QA” kept at QA Office.
Quality Non-impacting incidents :
Quality Non-impacting incidents are occurrences during the execution of an activity that may have no impact on the Quality, Purity, and Strength of a drug product.
Discrepancies in issuing requested Batch Production Record, Worksheet, Computer generated labels, etc.,
Minor Deviations from SOPs.
The above examples of quality non-impacting incidents shall be addressed as per the SOP on ‘Correction of Documentation Errors’ in the respective document.
Forms and Records (Annexures)
Specimen format of “Incident Report” – Annexure-1.
Specimen format of “Incident Report Register ” – Annexure-2.
Master copy – Quality Assurance
Controlled copies- Quality Assurance, Production, Quality Control. engineering
Specimen format of “Incident Report”
- INCIDENT REPORT
- IR No. ______________
- Date Observed:_____________________
- Due date:___________________________
- Brief description of the Incident:
- Corrective Action:
- Disposition :
Specimen format of “Incident Report Register ”
Incidents Report Register
Brief Description of the Incident