SOP for Handling of Incidents in Pharmaceuticals

PURPOSE

To define the procedure for event and incident reporting and investigation. Also to lay down a procedure to describe the incident, its classification, the requirement of investigation, and its reporting procedure.

SCOPE

This procedure is applicable to all types of incidents occurring, 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.

RESPONSIBILITY

Department:

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

Department In-charge / Department Head:

• To ensure that the event is reported to QA.
• To assign responsibility to the concerned person to investigate the 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

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Quality Assurance

• To register an event/incident and assign a sequential number to each event/incident.
• To evaluate the impact on the 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 reports.
• 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.

Quality Head

• To monitor the activity as per SOP.
• To review and approve event investigation reports wherever required.
• To review and approve incident investigation reports.
• To inform the Qualified person in case of EU and other countries as applicable in case of incidence.

Factory Head

• Review and approval of event investigation report wherever required.
• Review and approval of incident investigation report.

Distribution

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

DEFINITION

What is an Incident: An incident is a sequence of events or conditions that could result in an accident, injury, occupational illness, and/or property damage. In other words any unplanned events or series of events that cause, bodily injuries, fire, or damage to the environment, equipment, and property. Incidents are not welcome situations.

Accident: A workplace incident that has caused bodily injuries to human beings, and damage to the environment, equipment, and property.

Near Miss: It is also known as Learning Incident. Near misses are events other than dangerous occurrences, which have the potential to become an incident and require action to prevent occurrences. (E.g. Slip/trip/fall, sparking / smoke, minor overflow/leaks, failure of the valve, etc.

Near misses describe incidents where no property was damaged and no personal injury was sustained, but where given a slight shift in time or position, damage and/or injury easily could have occurred.

First Aid Incident (FAI): A workplace incident that causes minor injury like cuts, scratches, burns, etc. to the person and is treated immediately by trained first aiders. After the first aid treatment, the person will resume back to work.

Fire Incidents: An unplanned combustion that leads to heat, smoke, and flames is called a fire incident.

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Environmental Incidents: Any incidents that have potentially adverse impacts on the environment are classified as environmental incidents. A major spillage or leakage of toxic and hazardous chemicals from the primary equipment (E.g. pipes, valves, tanks) to air, ground, or water.

Vehicle Incidents: These are the incidents related to incidents involving vehicles within the operating locations or employees traveling on company business.

Fatal Incident: Any incident which results in death. This includes all cases involving employees/contractors/visitors.

Prosecution Notification: Notifications from regulatory authority regarding prosecution or fine on account of any infringements to safety or environmental laws and regulations.

Occupational Illness: A disease or illness caused by repeated or prolonged exposure to a workplace hazard as well as acute & chronic illness or diseases caused by inhalation, ingestion, absorption or direct contact.

Medical Treatment Incident (MTI): A workplace incident that causes injury and requires treatment by an off-site medical professional or physician. Once the treatment is completed, the person will come back to work on the same day or the next day.

Lost Time Incident: A workplace incident that causes minor injury and prevents the person from joining back his duty the next day.

Reportable Lost Time Incident: A workplace incident or any dangerous occurrence causes injury and prevents the person from joining back his duty for more than 48 hours.

PROCEDURE

• Employees shall notify the department head in case of any incident.
• The department head shall assess if the standard procedure is violated and based on the assessment, it shall be either logged as an incident or deviation.
• Standard procedure violation shall be considered as deviation and shall be handled through deviation SOP. Any untoward and accidental event shall be considered as an incident.

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• Below are the non-exhaustive examples of incidents:

1. Accident
2. Fire
3. Accidental breakdown of equipment/instrument
4. Accidental spillage of materials
5. Error in contractor’s/vendor’s document
6. Handling loss or glassware breakage in the QC laboratory
7. Incorrect weighing
8. Incorrect calculation and incorrect data representation

• After confirmation from the department head, the concerned person shall request the QA department for issuance of an ‘incident form’.
• A designated person from QA shall issue the form and shall log the incident details in the ‘incident log’.
• Each incident shall be assigned a unique number as per the below format:

NNN/I/YYYY 

Where; 

NNN – Serial number,  

I – Incident,   

YYYY – Year

• The concerned department person shall fill out the incident form.
• The investigation shall be performed by the concerned department head or designated person to identify the root cause; wherever necessary it shall be jointly performed with other departments like quality assurance, quality control engineering, etc.
• The investigation shall be recorded in an incident form. Attachment can be incorporated wherever required.
• Based on the investigation outcome; corrective and preventive actions shall be proposed by the concerned department head or designated person and shall be approved by the QA head.
• Each corrective and preventive action shall be assigned a target completion date.
• A designated person from QA shall verify the completion of corrective and preventive actions and shall record the actual completion date in the form. Delay from the target date shall be justified.
• QA department head shall approve the fully filled incident form.
• A designated person from QA shall update the incident log after the closure of the incident.
• The incident form shall be archived and retained by the QA department.
• The incident shall be closed within 30 days from initiation. Delay in closure shall be justified.

ABBREVIATION

QA: Quality assurance

CAPA: Corrective and preventive actions

ANNEXURES

Annexure-1: Incident Log

Annexure-2: Incident Form

REVISION HISTORY

Nil

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