Table of Contents
1.0 OBJECTIVE:
1.1 To lay down the Procedure for Event and Incident reporting and Investigation.
2.0 SCOPE:
2.1 This SOP is applicable for investigating and detailing the sequence of events needed for handling of incidents occurred inadvertently in any department.
3.0 RESPONSIBILITY:
3.1 Officer-Concern department
3.2 Manager-Concern department
4.0 ACCOUNTABILITY:
4.1 Head-Quality Assurance
5.0 PROCEDURE:
5.1 Incidence is defined as something non CGMP have occurred all of sudden which may or may not have impact on product Quality.
5.2 An incident can happen any time which shall be recorded, investigated and closed with suitable preventive action plan.
5.3 Incidents are categorized as :
5.3.1 Quality Impacting Incidents:
5.3.1.1 Quality Impacting Incidents are unplanned events / errors that occur during the execution of an activity in any departments which may have impact on the quality, purity and strength of the drug material / product.
5.3.2 Quality Non-Impacting Incidents:
5.3.2.1 Quality Non-Impacting Incidents are unplanned events / errors that occur during the execution of an activity in any departments which have no impact on the quality, purity and strength of the drug material / product.
5.4 Following are the examples of incidents may happen but not limited to;
5.4.1 Unexpected major machine breakdown.
5.4.2 Unexpected deviation from environmental conditions.
5.4.3 Unexpected damage to the facility.
5.4.4 Unexpected power failure and no immediate backup support from electric generator which could cause a major product quality, quantity, safety and commercial issues.
5.4.5 Spillage of material during batch processing which could affect product yield and commercials.
5.4.6 Human accidents during development, manufacturing, packing, engineering, analytical work etc.
5.4.7 Commercial losses due to intentional/unintentional error and negligence.
5.4.8 Indiscipline behaviour from staff/workers inside the facility which can give impact on product quality, quantity and resulting into a major commercial loss.
5.5 On occurrence/ noticing of incidents the employee shall immediately inform, verbally or telephonically to the concerned shift-in-charge, who shall decide whether to continue the process or stop the process.
5.6 Shift-in-charge shall inform the concerned head of department.
5.7 Incident shall be immediately reported by the concerned department Head to quality assurance head and shall request for issuance of “Incidents Form”.
5.8 As per verbal request from any departmental head or his/her designee, chemist and above of Quality Assurance department will issue blank working copy of incident form by allocating incidents report numbers will also get acknowledgement from requesting own department on format issue register.
5.9 The incident request department shall enter the detail in Incident reporting form.
5.10 Each all incident shall be assigned unique number as per below format.
5.10.1 XX/INC/00/000 Where,
5.10.2 OR : OSCAR REMEDIES
5.10.3 INC : Incident
5.10.4 00 : Year in which incident occurred
5.10.5 000: Serial number of Report
5.11 Head-Quality Assurance on receipt of an incident form filled and signed from respective department, looking at seriousness of the incident shall plan immediate action, if necessary by taking support from other departments.
5.12 To be enter the incident details into the “Incident Register” as per Annexure:QA005-A01“Incident Control Register”
5.13 On the basis of the brief description of the incident the Head-QA decide the category of the incident (Quality Impacting Incident / Quality Non- Impacting Incident).
5.14 Preliminary investigation of the incident is done by respective department head to find out the root cause for the incident and the same is written in the Preliminary Investigation (root cause for incident) column with sign & date.
5.15 Department Head to be choose the correct option to specify the details of the events or errors.
5.16 Based on the identified error, the Corrective Action and Preventive Action (CAPA) is suggested by Department Head and the job is assigned to responsible person of department and date of completions is written in targeted date to be completed column.
5.17 Department Head then forward the Incident Report to Head- Quality Assurance for Evaluation and Recommendation.
5.18 Head-Quality Assurance evaluate the Incident Report and provide the recommendations, if any, and return back the Incident Report to respective department.
5.19 The above information is checked by department Head and if found ok, submit the Incident Report to Quality Assurance department for recommendation and closure.
5.20 Head-Quality Assurance shall make sure that all the Corrective Action and Preventive action are completely carried out as per suggestions given by department Head and Head-Quality Assurance.
5.21 If the verification found satisfactory, Head-Quality Assurance fills the respective compliance details in the Compliance of the Recommendations column and carry out the Closure of the incident.
5.22 After performing detailed investigations and impact of the incidents, Head-Quality Assurance shall prepare a report on incident with final conclusion and state the remarks.