1.0 Objective
To lay down a procedure for handling of incidents.
2.0 Scope
This Standard Operating Procedure is applicable for pharmaceutical formulation plant.
3.0 Responsibility
3.1 Executive / Supervisor of concerned department shall be responsible for performing the technical evaluation and mitigation of incidents as per this SOP.
3.2 Officer / Executive QA shall be responsible for investigation of incident as per this SOP.
3.3 Head concerned department shall be responsible for implementation of this SOP.
3.4 Head QA/ designee shall be responsible for compliance of this SOP.
4.0 Abbreviations and Definitions
Incident: Is an event that may occur in facility, manufacturing operation /process or written procedures, which is directly or in-directly related to plant operations. An incident does not have any impact on the product quality.
IPQA : In-process Quality Assurance
5.0 Procedure
5.1 On occurrence of incident the employee shall immediately inform, verbally or telephonically to the concerned Supervisor /Shift-in-charge, who shall decide whether to continue the process or stop the process.
5.2 Supervisor /Shift-in-charge shall inform the concerned Head of Department or his/her designee.
5.3 Incident shall be immediately reported by the concerned department Head to quality assurance department.
5.4 QA shall issue incident report form to concerned department.
5.5 Any person can report the incident through the Incident report (Annexure-I) counter signed by immediate superior and department head of the reporter.
5.6 Concerned department shall fill the details as mentioned in the form and submit to QA.
5.7 QA shall assign incident report number to the form. Incident report number shall comprise of following characters:
“M” shall denote Mumbai location.
“IR” shall denote Incident report.
4th, 5 th and 6 th character shall denote serial number like 001, 002,…..so on.
7 th character shall be “/”.
8 th and 9th character shall represent the financial year i.e. 16 for April 2016 to March 2017 and so on.
Example: first incident report for financial year April 2016 to March 2017, for Mumbai location shall be MIR001/16.
5.8 Incident number shall change every financial year.
5.9 Executive/Officer QA shall submit the form to Head QA for review.
5.10 Head QA shall review the form and as per requirement permit designated persons from QA and concerned department’s to investigate the incident.
5.11 If any CAPA need to undertaken same shall be done as per respective SOP.
5.12 The designated person from concerned department shall submit completed investigation report (Annexure-I) to his/her department Head for review.
5.13 Concerned Department Head shall approve the report and report shall be submitted to QA.
5.14 QA personnel shall review the incident and conclude the cause of incident in his/her comments.
5.15 Is required corrective action shall be planned and CAPA shall be filled.
5.16 Finally completed report shall be submitted to Head QA for disposition.
5.17 After implementation of proposed corrective action Incident report shall be closed by Executive/Officer QA.
Authorization Note:
5.18 For incidents (change in any process or procedure, exhaustion of inventory, Use of different specification at different locations, etc.) which do not have any effect on product quality, purity and strength under the recommendation of QA in consent with all departments authorization note shall generated.
5.19 This shall be procedurelized by generating an authorization note by QA and getting acceptance / approval of all the concerned departments. The acceptance / approval can be sought through electronic mails. Printout of electronic mails shall be attached with Authorization note.
5.20 Final approval of Authorization note shall be given by Head QA.
6.0 Forms and Records
6.1 Incident Report Annexure-I
6.2 Incident Report Register Annexure-II
7.0 Distribution
7.1 Master Copy: Documentation Cell (QA)
7.2 Controlled Copies: Quality Assurance, Production, Stores, Engineering, Quality control, Administration.
8.0 History
| Date | Revision Number | Reason for Revision |
| – | – | New SOP |
Annexure-I
| Report No. | Date | Issued by | Issued to Department | Incident Reported by | Brief description of Incident | CAPA No.
(If Any) |
Closed by |
Annexure-II
