Incident / Accident Reporting in Pharmaceutical Plant SOP

Standard Operating Procedure of Incident / Accident Reporting in Pharmaceutical Plant SOP is describe in this post.

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1. Purpose:

1.1. The purpose of incident/accident report is to help Pharmaceuticals regarding manufacturing facilities, identify risks and thus eliminate hazards.         

2. Scope:

2.1. This procedure provides the guidelines for reporting accident resulting from work related injuries and investigation of all such accidents including measures to prevent recurrence. 

3. Responsibilities:

3.1. All Department Heads

3.2. QA Officer

3.3. Admin Officer

4. Procedure:

4.1. Reporting of Incident/Accident:

4.1.1. All employees especially section supervisors and department heads must report all Incidents/accidents or “near miss” on Incident/Accident report form. 

4.1.2. The report must be submitted to Admin department within 24 hours.

4.2. Corrective Action:

4.2.1. On receiving report, Admin Officer initiates immediate corrective action in case of serious injury by providing required first aid or arranging visit to nearby clinic/hospital in case of serious injuries.

4.3. Incident/Accident Investigation:

4.3.1. All the Incidents/Accidents regardless of severity must be investigated.

4.3.2. Section supervisor for the area where accident occurred conducts investigation with Admin officer to determine cause of the accident by observing the area/equipment & collecting information from workers present as well as from the injured employee.

4.3.3. Investigation team examines hazards and current controls available and determines preventive measures to be taken to avoid recurrence. The investigation report is then forwarded to Director for final closing.

4.4. Q.A. Officer maintains records of Incidents/Accidents at Bio-Mark Plant premises.

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