SOP for Incident Handling in Pharmaceutical Industry: PharmaState


  1. 1. Objective:

To lay down a procedure for handling of incidents.

  1. Scope:

This procedure is applicable for accidental and untoward events occurring in factory premises. Incidents may occur even though standard procedures are not violated.

  1. Responsibility:

All department

  1. Procedure:

4.1 Employee shall notify department head in case of any incident.
4.2 Department head shall assess if the standard procedure is violated and based on assessment, it shall be either logged as incident or deviation.
4.3 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:
– Fire
– Accidental breakdown of equipment/instrument
– Accidental spillage of materials
– Error in contractor’s/vendor’s document
– Handling loss or glassware breakage in QC laboratory
– Incorrect weighing
– Incorrect calculation and incorrect data representation    
4.4 After confirmation from the department head, concern person shall request QA       department for issuance of ‘incident form’.
4.5 Designated person from QA shall issue the form and shall log the incident details in    ‘incident log’.
4.6 Each incident shall be assigned unique number as per below format:
NNN/I/YYYY Where; NNN– Serial number, I– Incident, YYYY– Year
4.7 Concern department person shall fill the incident form.
4.8 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.
4.9 Investigation shall be recorded in incident form. Attachment can be incorporated       wherever required.
4.10 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.
4.11 Each corrective and preventive action shall be assigned target completion date.
4.12 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.
4.13 QA department head shall approve the dully filled incident form.
4.14 Designated person from QA shall update the incident log after closure of incident.
4.15 Incident form shall be archived and retained by QA department.
4.16 Incident shall be closed within 30 days from initiation. Delay in closure shall be         justified.
QA: Quality assurance
Annexure I_Incident Log
Annexure II_Incident Form
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