SOP for Incident Management and control
1.0 Objective :
To laydown procedure for handling of an incident.
2.0 Scope :
This SOP is applicable to handling of an incident to approved / established procedures.
This SOP is applicable to handling of an incident to approved / established procedures.
3.0 Responsibility:
Originating Department: To raise an Incident.
Originating Department Head/Designee: To review, investigate and plan for Corrective and Preventive actions.
Head/Designee QA or authorized designee: To review the Incidents.
Head/Designee – QA: To ensure the compliance.
4.0 Procedure:
4.1 Incident may occur in Production, QC, Microbiology, Engineering, Stores or any other area. e.g.: Breakdown of processing equipment / Instrument while the batch is going on. Note: In Exhibit / validation batches, the incident shall be recorded in respective batch documentation and shall be verified and / or amended in subsequent batches.
4.2 It may arise due to break down or failure of the following but not limited to:
A. An Equipment, B. Malfunctioning of Instrument, C. Utility / Service, D. Human Error, E. any other.
A. An Equipment, B. Malfunctioning of Instrument, C. Utility / Service, D. Human Error, E. any other.
4.3 Incident shall be brought to notice by Technical staff / Operating Staff to the Head/Designee of department.
4.4 Concerned Department designee shall inform to QA, to assign incident number.
4.5 QA Designee shall assign the Incident number to the issued form as per in-House pattern.
Pattern should include-
- Company name
- Incident department
– Serial no. start of incident in current calendar year.
– Last two digits of current calendar year
- Company name
- Incident department
– Serial no. start of incident in current calendar year.
– Last two digits of current calendar year
4.6 Initiator shall fill the Incident details, root cause for incident, immediate action taken with sign and date.
4.7 Initiator along with QA Designee upon primary investigation shall write his comments on incident along with the proposed corrective action(s). The investigation should be extended to other batches or similar issues in the past.
4.8 Head/Designee of the Department upon primary investigation shall assess the incident along with the proposed corrective action(s). The investigation should be extended to other batches (if required) or similar issues in the past.
4.9 Head/Designee of the Department shall forward the Incident to Head/Designee - QA for review.
4.10 Head/Designee - QA shall review the impact of incident on the product quality, process performance, yield, cGMP, analytical requirements, any other department evaluation requirement and any similar deviations in past.
4.11 The details of incidents related to product or affecting the products covered under contract manufacturing shall be communicated to Contract Giver for evaluation and comments (electronic / facsimile acceptance from Contract Giver / MA holder will be considered as valid confirmation of the incident).
4.12 Head/Designee - QA shall assess the incidents and the corrective actions suggested by the Head/Designee of department.
4.13 Head/Designee - QA shall extend the assessment to other batches or similar incident in the past, and shall recommend the additional testing(s), corrective and preventive steps on product / process if required, based on the validation data and past experience.
4.14 Based upon the assessment of the corrective and preventive actions planned taken, Head/Designee - QA shall decide for any change in the facility/ system through the change control procedure
4.15 The final decision shall be written by Head/Designee - QA on incident form with signature and date.
4.16 Write the incident number in the affected batch documentation of a product or at the respective document / area where the Incident is taken.
4.17 The incident shall be closed by Head/Designee of department in consultation with Head/Designee - QA before batch is approved / released.
4.18 Incident form must be closed within 30 working days time period from initiating date. If any of the action goes beyond the closure date, then the same shall be justified, if required CAPA shall be initiated and logged.
4.19 Quality Assurance department shall file the original closed incident record and a copy of the same shall be filed in the affected Batch records or related documentation in which incident is taken.
4.20 Head/Designee - QA will take the batch release decision subject to additional testing required, if any, at the end of the batch completion.
4.21 QA designee shall log the details of incidents in the incident Register.
4.22 QA designee shall retrieve and destruct all invalid incident form at the end of year and issue new incident from to all department & record the same.
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