Handling of Incident during operation
1.0 OBJECTIVE :
1.1 To lay down a procedure for handling, reporting, investigation and closing of incident during operation.
2.0 SCOPE :
2.1 This Standard Operating Procedure is applicable for all Incidents during operation and that can directly/ indirectly affect the quality of the product to be followed at formulation plants of ……….
3.0 RESPONSIBILITY :
3.1 Officer / Executive of initiator department shall be responsible for
3.2 Brief description of the incident shall be written where the incident has occurred.
3.3 A personnel who is reporting shall sign with date and forward the report to their department head.
3.4 In charge / head of concern department shall be responsible for the investigation and review of the report with sign and date and forward the report to QA department.
3.5 In charge / his designee shall be responsible for its investigation, completeness and allocate the Incident Report number with recording in the log book and submitted to Head-QA for comments.
3.6 Head QA / his designee shall be responsible for compliance of this SOP.
4.0 ACCOUNTABILITY:
4.1 Concern Department Head / QA Head.
5.0 PROCEDURE:
5.1 Identification of Incident
5.2 Personnel of concerned department shall report immediately to responsible officer or concerned department head must identify incidents.
5.3 Following are the examples of incidents, but not limited to
5.4 Spillage of raw/ packing material.
5.5 Damage of container carrying raw, bulk, semi finish or finish material.
5.6 Error notify during the operation, machine handling or automation or sudden temporary/ permanent break down of machine equipment.
5.7 Any mishandling observes during the operation, packing, over printing etc.
5.8 Reporting of Incident
5.9 Officer / Executive of the concerned department shall initiate Incident Report as per Annexure-1.
5.10 The form shall be clearly filled and no abbreviations shall be used while filling the Incident Report.
5.11 Incident Report shall be clearly filled for Date of Incident, Department Name, Product Name and details as per Annexure-1.
5.12 Brief description of the incident shall be written where the incident has occurred.
5.13 Immediate action taken (if any) after the incident, the same shall be recorded in the report.
5.14 A personnel who is reporting shall sign with date and forward the report to departmental head for Assessment.
5.15 Assessment by concerned department head and Manager-QA.
5.16 The departmental head shall review the report & comment with signature and date and forward the report to QA department.
5.17 The QA department shall check the report for its completeness and allocate the Incident report number with recording in the logbook and submitted to Manager–QA for comments.
5.18 The Incident Report Number shall be allocated as IN/ YY / NNN where:
“IN”– Denotes the Incident
“YY”– Last two digits of Calendar year
“NNN”– Serial number of the Incident form raised in current Calendar Year.
For example: IN /19/001 denotes first Incident Report No. raised in year 2019.
5.19 Investigation Report
5.20 On the receipt of Incident Report, Manager-QA shall review the impact on the quality of product and comment with signature and date.
5.21 If Manager-QA shall recommend for investigation, the investigation shall be carried out.
5.22 If investigation is not required, departmental Head along with the target date of completion, signature and date shall mention the details of Corrective and Preventive Action (CAPA) taken.
5.23 QA department shall monitor the compliance of CAPA.
5.24 The CAPA shall be duly approved by Head-QA and Authorized by Plant Head / Director.
5.25 Closure of Incident Report
5.26 After closing the Incident report, the same shall be submitted to QA department and documented in Incident Log Book as per Annexure-2.
6.0 ABBREVIATION:
| Sr. No. | Abbreviation used | Full form of abbreviation used |
| 1.0 | SOP | Standard Operating Procedure |
| 2.0 | BMR | Batch Manufacturing Record |
| 3.0 | BPR | Batch Packing Record |
| 4.0 | CAPA | Corrective and Preventive Action |
7.0 ATTACHMENTS (ANNEXES) :
Annex-I : Incident Report
Annex-II : Incident Logbook
8.0 REFERENCE
| Sr. No. | Reference Title |
| 1.0 | Schedule M (Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products) of Drugs and Cosmetics Act-1940, Drugs and Cosmetics Rules-1945, India |
— -Annex-I : Incident Report
— QUALITY ASSURANCE
INCIDENT REPORT
| INCIDENT REPORTING | ||||||
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Date of Incident:
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Department:
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| Product Name:
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Batch No.:
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| Batch Size: Manufacturing Date: Expiry Date:
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| Description of Incident*:
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| Immediate Action taken(if any)*:
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| Reported By:
Name:________________ Signature:___________________ Date:____________________
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Comments: HOD Concern Department:
Name:_______________ Signature:___________________ Date:______________________
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| Comments: Manager QA:
Name:_______________ Signature:___________________ Date:______________________
Investigation required: Required Not Required
3.1 If Investigation Required
3.2 If Investigation not required
Corrective and Preventive Action Recommended (CAPA)
Responsible Person for completion of Action:
Target Date for Completion:
CAPA Proposed by (Departmental Head):
Name: ______________________ Sign. /Date: _____________________
CAPA Approved by: Authorized by: (Head QA) (Plant Head/Director)
Name: ________________ Name: _______________
Sign/Date: __________________ Sign/Date: ______________
Submission to Document cell on: _____________________________ Sign/Date:___________________
* Use Extra Page if Required. |
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Annex-II : Incident Logbook
Handling of Incident during operation
Receipt of Batch from Production to Packing Department
sop for for Spillage Handling in parenteral area
sop for calibration of vessels with dipstick
sop for Cleaning of Bins and Containers
cip of mixing vessel and holding vessel
sop for Cleaning of Ampoule Filling and Sealing Machine
sop for Fogging in Sterile and Non Sterile Area
sop for for Filtration of Bulk Solution
sop for fumigation in production area
sop for post cleaning after media fill
sop for cip of mixing vessel mixing mobile vessel and holding vessel
sop for De-Bagging of Three Piece Vial Dropper Caps
sop for calibration and verification of check weigher
sop for Batch number and Manufacturing and Expiry Date Coding System
standard operating procedure machine history file
sop for operation and cleaning of Hand coder
sop for Cleaning and Handling and Silicone Tubes
sop on operation and cleaning of coating pan
sop for Operation of cleaning of pipe lines
sop for operation of capsule loading machine semi automatic
sop for Machine operation capsule inspection and polishing machine
Sop batch demarcation and batch coding
sop for monitoring of reprocessing of products
sop for in-process control on liquids orals
sop for in process controls on tablets capsules packaging line
sop for Issuance retrieval and destruction of BMR and analytical records
sop for in process controls during granulation compression coating inspection
sop for Cleaning of Blister packing machine
sop for for charge hand over between the shifts
Performance requalification report of visual inspectors
sop for Cleaning and operation of ROPP caps inspection table
sop for usage and destruction of filter pad and cartridge filter
sop for cleaning and storage of transfer pipe
sop for Cleaning and operation of labeling machine
Cleaning and operation of the mono block filling and sealing machine
sop for Cleaning and operation of empty bottle inspection table
sop for Cleaning and operation of filter press
sop for cleaning and operation of liquid transfer pump and line