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.
1.0
PROTOCOL APPROVAL:
The Risk Assessment Protocol has been reviewed and approved by the following persons:
FUNCTION
NAME
DEPARTMENT
SIGNATURE
DATE
PREPARED BY
QUALITY ASSURANCE
REVIEWED BY
PRODUCTION
REVIEWED BY
QUALITY CONTROL
REVIEWED BY
PROJECTS / ENGINEERING
APPROVED BY
QUALITY ASSURANCE
SERIAL NO.
ITEM DESCRIPTION
1.0
PROTOCOL APPROVAL
2.0
OVERVIEW:
2.1
Objective
2.2
Purpose
2.3
Scope
2.4
Responsibility
2.5
Execution Team
3.0
GENERAL CONSIDERATION/PREREQUISITES
4.0
RISK ASSESSMENT CRITERIA
5.0
RISK ASSESSMENT PROCEDURE
6.0
ACCEPTANCE CRITERIA
7.0
UNIT OPERATION REVIEW
8.0
FEMA TABLE
9.0
RISK IDENTIFICATION SUMMARY
10.0
RISK MITIGATING TOOLS
11.0
RISK PREVENTION TOOLS
12.0
DEFICIENCY, CORRECTIVE AND PREVENTIVE ACTION:
13.0
RISK EVOLUTION SUMMARY
14.0
ANNEXURE (S)
15.0
RISK ASSESSMENT FINAL REPORT
15.1
Summary
15.2
Conclusion
15.3
Final Report Approval
16.0
REFERENCES
2.0
OVERVIEW :
2.1
OBJECTIVE:
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.
2.2
PURPOSE:
The purpose of this protocol is to verify the actual risk associated with critical operations at Pharmaceutical manufacturing
2.3
SCOPE
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.
2.4
RESPONSIBILITY:
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.
2.5
EXECUTION TEAM:
The execution team is responsible for the execution of risk assessments study it compresses of
DEPARTMENT
DESIGNATION
NAME
SIGNATURE
DATE
PROJECTS
PRODUCTION
QUALITY CONTROL
QUALITY ASSURANCE
3.0
GENERAL CONSIDERATION/PREREQUISITES
3.1
All areas/equipment will be qualified against approved protocol.
3.2
All 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.
5.0
RISK 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
6.1
It 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.
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