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Risk Assessment Protocol in Pharmaceuticals

The objective of developing and executing this Risk Assessment Protocol is To access the Risk Associated with the Quality of the product with respect to hazards and critical point review. To evaluate the risk priority Number To identify the risk prevention steps. To identify the risk mitigation tools.

1.0PROTOCOL APPROVAL:

The Risk Assessment Protocol has been reviewed and approved by the following persons:

FUNCTIONNAMEDEPARTMENTSIGNATUREDATE
PREPARED BY QUALITY ASSURANCE  
REVIEWED BY PRODUCTION  
REVIEWED BY QUALITY CONTROL  
REVIEWED BY PROJECTS / ENGINEERING  
APPROVED BY QUALITY ASSURANCE  
SERIAL NO.ITEM DESCRIPTION
1.0PROTOCOL APPROVAL
2.0OVERVIEW:
2.1Objective
2.2Purpose
2.3Scope
2.4Responsibility
2.5Execution Team
3.0GENERAL CONSIDERATION/PREREQUISITES
4.0RISK ASSESSMENT CRITERIA
5.0RISK ASSESSMENT  PROCEDURE
6.0ACCEPTANCE CRITERIA
7.0UNIT OPERATION REVIEW
8.0FEMA TABLE
9.0RISK IDENTIFICATION SUMMARY
10.0RISK MITIGATING TOOLS
11.0RISK PREVENTION TOOLS
12.0DEFICIENCY, CORRECTIVE AND PREVENTIVE ACTION:  
13.0RISK EVOLUTION SUMMARY  
14.0  ANNEXURE (S)  
15.0RISK ASSESSMENT FINAL REPORT  
15.1Summary  
15.2Conclusion  
15.3Final Report Approval  
16.0REFERENCES  

2.0
OVERVIEW :
2.1OBJECTIVE: 
 The objective of developing and executing this protocol is To access the Risk Associated with the Quality of the product with respect to hazards and critical point review. To evaluate the risk priority Number To identify the risk prevention steps. To identify the risk mitigation tools.
2.2PURPOSE: 
 The purpose of this protocol is to verify the actual risk associated with critical operations at Pharmaceutical manufacturing
2.3SCOPE
 The protocol shall define the risks and determine critical operations. Based upon the initial risk assessment, risk prevention, and risk mitigation tools will be designed.
2.4RESPONSIBILITY: 
 The following functionaries are responsible to prepare the protocol and for Execution Quality assurance officer/Executive  – For Preparation /Execution of Protocol Engineering Head – For execution support Production Head – For execution support Quality Control head – For execution support Quality Assurance Head – For adequacy of Protocol with Respect to regulatory requirement and final approval.
2.5EXECUTION TEAM:
 The execution team is responsible for the execution of risk assessments study it compresses  of
DEPARTMENTDESIGNATIONNAMESIGNATUREDATE
PROJECTS    
PRODUCTION    
QUALITY CONTROL    
QUALITY ASSURANCE    
3.0GENERAL CONSIDERATION/PREREQUISITES
3.1All areas/equipment will be qualified against approved protocol.
3.2All the deficiencies and discrepancies related to the area/equipment operation which affect the product quality and corrective action taken shall be recorded in the appropriate section of the protocol.

4.0
RISK ASSESSMENT CRITERIA:
 Risk Assessment activity shall cover all the critical aspects of pharmaceutical quality including raw material management, dispensing, manufacturing, testing, and distribution processes throughout the lifecycle of drug substances, drug products.    
5.0RISK ASSESSMENT  PROCEDURE
 Risk=Severity ×Probability  of Occurrence   Risk assessment team will identify risk using unit operation review format. Based upon identified risk in unit operation review, risk evaluation will be done and risk priority number will be identified. Risk priority number will take into account severity of risk associated and probability of occurrence and take delectability.  The risk team will evaluate risk prevention and risk mitigation tools. Management action plan with a timeline will be associated with sound judgment & hazards associated with the criticality of that hazard. Re-evaluation will be conducted based upon the timeline provided within the plan.  
6.0 RISK ACCEPTANCE CRITERIA
6.1It is a decision to accept risk. Risk acceptance can be a formal decision to accept the residual risk or it can be a passive decision in which residual risks are not specified. The acceptable level will depend on many parameters and will be decided on a case-by-case basis.  
RISK ASSESSMENT PROTOCOL
RISK ASSESSMENT PROTOCOL
RISK ASSESSMENT PROTOCOL
9.0 RISK IDENTIFICATION SUMMARY
RISK IDENTIFICATION SUMMARY
RISK MITIGATING TOOLS

Sign and Date:

11.0 RISK PREVENTION TOOLS
RISK PREVENTION TOOLS

Sign and Date

Deficiency, Corrective and Preventive Action:

Date and Sign:

13.0 RISK EVALUATION SUMMARY
RISK EVALUATION SUMMARY

Date and Sign:

annexure for RISK ASSESSMENT PROTOCOL
15.0 RISK ASSESSMENT FINAL REPORT:
RISK ASSESSMENT PROTOCOL

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