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SOP for Handling of Incident in Pharmaceuticals

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

This procedure is applicable all types of incident 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.

  • 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.

Department In-charge / 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

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.

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.

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

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

What is 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 which cause, bodily injuries, fire, damage to environment, equipment and property. Incidents are not welcome situations.

  • A workplace incident which has caused bodily injuries to human beings, damage to environment, equipment and property.

Near Miss:
  • It is also known as Learning Incident. Near misses are the event other than dangerous occurrences, which have 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 describes incidents where no property was damage and no personal injury 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 which cause minor injury like cuts, scratches, burns etc. to the person and are treated immediately by trained first aiders. After the first aid treatment, the person will resume back to work.

Fire Incidents:
  • An unplanned combustion which leads to heat, smoke and flames is called as fire incidents.

Environmental Incidents:
  • Any incidents that have potential adverse impacts on 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 employee travelling 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 diseases 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 which cause 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 same day or next day.

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

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

  • Employee shall notify department head in case of any incident.
  • Department head shall assess if the standard procedure is violated and based on assessment, it shall be either logged as 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 incident.
  • Below are the non-exhaustive examples of incident:
  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 QC laboratory
  7. Incorrect weighing
  8. Incorrect calculation and incorrect data representation
  • After confirmation from the department head, concern person shall request QA department for issuance of ‘incident form’.
  • Designated person from QA shall issue the form and shall log the incident details in ‘incident log’.
  • Each incident shall be assigned unique number as per below format:
                     NNN– Serial number,  I– Incident,  YYYY– Year
  • Concern department person shall fill the incident form.
  • Investigation shall be performed by concern department head or designated person to identify the root cause; wherever necessary it shall be jointly performed with other department like quality assurance, quality control and engineering etc.
  • Investigation shall be recorded in incident form. Attachment can be incorporated wherever required.
  • Based on investigation outcome; corrective and preventive actions shall be proposed by concern department head or designated person and shall be approved by QA head.
  • Each corrective and preventive action shall be assigned target completion date.
  • Designated person from QA shall verify the completion of corrective and preventive actions and shall record the actual completion date in form. Delay from target date shall be justified.
  • QA department head shall approve the dully filled incident form.
  • Designated person from QA shall update the incident log after closure of incident.
  • Incident form shall be archived and retained by QA department.
  • Incident shall be closed within 30 days from initiation. Delay in closure shall be justified.

QA: Quality assurance
CAPA: Corrective and preventive actions



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