SOP for Incident Reporting and Investigation : Pharmaguideline

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SOP for Incident Reporting and Investigation

Standard operating procedure to report and investigate the event and incident in pharmaceuticals.

1.0 Objective

To define the procedure for event and incident reporting and investigation.

2.0 Scope

This guideline is applicable to all events and incidents (except equipment or machine breakdown related), which can affect the safety, identity, strength, purity and/ or quality of the product which can be,
Facility related.
Storage related.
Production-related or occurred during processing.
Raw/ Packaging / FP sampling, testing or release related.
Distribution related.
Confirmed failures out of repeat analysis and out of specification investigations.
Unplanned deviations from approved procedures e.g. Standard operating procedure, protocol, BMR etc., without prior authorization and documentation.
Any other.
Note: Events related to equipment or machine breakdown shall be handled through breakdown maintenance system.

3.0 Responsibilities

3.1 Concerned Person

To report the event to a supervisor or department head and/ or Quality Assurance.
To investigate the event/incident.
To evaluate the impact on quality of the product.
To prepare the event/incident investigation report.

3.2 Department Head

To ensure that event is reported to QA.
To assign responsibility to concerned person to investigate event/incident.
To provide the guideline for investigation of the event/incident.
To review and approve the event/incident investigation report.
To monitor the CAPA.

3.3 Quality Assurance

To register event/incident and assign a sequential number to each event/incident.
To evaluate the impact on quality of the product and to allow the process to continue to the next phase of manufacturing, packing or release for distribution, if no impact is evident.
To review and approve event/incident investigation report.
To close the event/incident investigation report.
To monitor recommended corrective action / and implementation through relevant SOP.
To monitor the event and incident investigation and closing as per procedure and timelines defined in SOP.

3.4 Quality Head

To monitor the activity as per SOP.
To review and approve event investigation report wherever required.
To review and approve incident investigation report.
To inform the Qualified person in case of EU and other countries as applicable in case of incidence.
3.5 Factory Head
Review and approval of event investigation report wherever required.
Review and approval of incident investigation report.

4.0 Distribution

Quality Assurance
Production Department
Engineering Department
Warehouse Department
QC Department
Personnel Department

5.0 Procedure

5.1 Event

5.1.1 Any unforeseen event.
5.1.2 Deviations from approved protocols or standard operating procedures without prior authorization and documentation.
5.1.3 Any variance from established specification or requirements stated in quality system document, which includes but not limited to SOP (Standard Operating Procedure), BMR (Batch Manufacturing Record), PO (Packing Order), that would affect the safety, identity, strength, purity and/or quality of the product.
5.1.4 Activity or the operation performed in excess of that defined in a BMR, SOP or other approved documents (BMR may allow adjustment of machine, pH, however on an excessive number of adjustment is an event).

5.2 Incident

5.2.1 It is similar to the event but requires extensive investigation if the assignable cause is not identified while event investigation /repetitive event or breakdown of equipment or machine / there is the impact on other batch/es.

5.3 Investigation

5.3.1 General process of information or data gathering, analysis & checking possible causes to find out the cause.

5.4 Repetitive events/ equipment breakdowns

5.4.1 Same event occurring in the same product more than once. e.g. less yield in same product batches or different product batches processed on same machine/equipment.
5.4.2 Same equipment failure/process parameter out of limit occurring in same equipment more than once. e.g. temperature out of limit during the coating process.
5.4.3 The same equipment failure/ process parameter out of limit occurring in different equipment/ machine due to a common utility problem. e.g. cooling zone temperature out of limit in different tunnels.

5.5 Corrective action

5.5.1 The term "correction" usually refers to the repair, rework or adjustment made to the product as part of the disposition of an existing nonconformity.
5.5.2 A corrective action is action taken to eliminate the causes of an existing non-conformity, defect or other undesirable situation in order to prevent recurrence.
Note: There can be more than one cause for a nonconformity. Corrective action is taken to prevent recurrence whereas preventive action is taken to prevent the occurrence.
5.5.3 In ISO and other guidances three terms are used to explain CAPA. i.e. Correction, Corrective action and Preventive action. But for easy understanding, only two terms are used in below examples.

5.6 Preventive action

A preventive action is an action taken to eliminate the cause of a potential nonconformity, defect or other undesirable situation in order to prevent its occurrence.
Note: There can be more than one cause for a potential nonconformity.
Preventive action is taken to prevent occurrence whereas corrective action is taken to prevent recurrence.

5.7 Examples of Corrective action and Preventive action

5.7.1 Incident: Punch breakage while compression of drum no. 5.
Cause identified: Wear and tear on the prolonged use of the punches.
Corrective actions: 1) Passed the compressed tablets of drum number 5 through the metal detector. 2) Replaced the broken punch with new punch set. 3) Destroyed the punch set.
Preventive action: To restrict the use of the toolset up to compression of X million tablets.
5.7.2 Incident: After drying, the yield of lubricated granules found approximately X kg less.
Cause identified: Particle flow sensor of FBD was switched off. The operator was not aware of the importance of the sensor.
Corrective actions: 1) Qty of lubricants reduced proportionately before lubrication. 2) Training is given to the concerned.
Preventive action: The particle flow sensor shall be put on during the drying operation and shall be ensured by the supervisor and shall be made as a part of FBD checklist.
5.8 Root Cause: The identifiable factors based on objective evidence which have been determined to be responsible for the incident are known as root cause.
5.9 Probable Cause: The identifiable factor(s) which is most likely to be responsible for the incidence.

6.0 Abbreviations

6.1 CAPA: Corrective and preventive actions
6.2 BMR: Batch manufacturing record.
6.3 SISPQ: Safety, Identity, Strength, Purity and Quality.
6.4 FDA: Food and drugs administration.
6.5 EIR: Event investigation report.
6.6 ISO: International organization for standardization.
6.7 CDER: Center for drug evaluation and research.
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