RISK ASSESSMENT STUDY PROTOCOL

 

 

 

Protocol For RISK ASSESSMENT STUDY

 

 

Document No.	PRT/RAS/01/00
Effective Date	23-11-2009
No. Of Pages	11

 

Site Address----------------

 

 

 

 

PROTOCOL CONTENTS

 

S. NO.	ITEM DESCRIPTION	PAGE NO.
1.0	Protocol approval	3
2.0	Overview:	4
2.1	Objective	4
2.2	Purpose  and Scope	4
3.0	Execution Team  and Responsibility	5
3.0	GENERAL CONSIDERATION/PREREQUISITES	6
4.0	RISK ASSESSMENT CRITERIA	6
5.0	RISK ASSESSMENT  PROCEDURE	7
6.0	RISK ACCEPTANCE CRITERIA	8
7.0	UNIT OPERATION REVIEW	8-9
8.0	FEMA TABLE	10
9.0	RISK IDENTIFICATION SUMARY	11
10.0	RISK MITIGATING TOOLS	12
11.0	RISK PREVENTION TOOLS	13
12.0	DEFICIENCY ,CORRECTIVE AND PREVENTIVE ACTION:	14
13.0	RISK EVOLUTION SUMMMARY	15
14.0	ANNEXURE (S)	16
15.0	RISK ASSESSMENT FINAL REPORT	17
15.1	Summary	18
15.2	Conclusion	18
15.3	Final Report Approval	18
16.0	REFERENCES	19

1.0         Protocol Approval

        This protocol shall be approved by the following 

	Name	Department	Designation	Signature	Date
Prepared By
Checked By
Reviewed By

                                     

Final Approval

Final approval shall be given by the following:

	Name	Signature	Date
Approved By (Head – QA)

 

 2.0      Overview:

2.1        Objective

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

 

2.2        Purpose  and Scope

The purpose of this protocol is to verify the actual risk associated with critical operation at formulation Unit -6 Nectar Lifesciences Limited, Barotiwala

 

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.

The Scope of the protocol is limited to conduct risk assessment study at formulation Unit -6 Nectar Lifesciences Limited, Barotiwala.

 

3.0        Execution team and Responsibility:

        3.1. Execution team responsible for the execution of risk assessments study, compresses of:

 

DEPARTMENT	DESIGNATION	NAME	SIGNATURE	DATE
PROJECTS
PRODUCTION
QUALITY CONTROL
QUALITY ASSURANCE

 

        3.2 Responsibility

                The following factionaries 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

     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 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 delectability and probability of occurrence and take delectability

·         Risk management team will evaluate risk prevention and risk mitigation tools

 

 

·         severity (S),

·         likelihood of occurrence (O), and (Note: This is also often known as probability (P))

·         inability of controls to detect it (D)

 

Each index ranges from 1 (lowest risk) to 10 (highest risk). The overall risk of each failure is called Risk Priority Number (RPN) and the product of Severity (S), Occurrence (O), and Detection (D) rankings: RPN = S × O × D. The RPN (ranging from 1 to 1000) is used to prioritize all potential failures to decide upon actions leading to reduce the risk, usually by reducing likelihood of occurrence and improving controls for detecting the failure

    6.0                                                                                                                                                                                                                                                                           Risk acceptance criteria

·         Severity ranking, occurrence ranking and delectability ranking should not exceed 5.

·         Individual Risk Priority Number should not increase 125.

·         RPN for a given high-risk process must be decreased by 50 percent within 1 year.

 

         

 

 

 

7.0     Unit operation review

Area /Equipment Code:

Key Operation:

Operating Personnel:

Time/date of Operation:

Dept. Officer:

Review By:

Date:

 

Sr.No.	Unit operation	Standard Practice	Observation	Probability of occurrence	RPN	Remarks

8.0     FMEA TABLE

 

Part Function	Failure Mode	Effect of Failure	Severity Ranking	Potential cause of Failure	Occurrence Ranking	Possible means of detection/Delectability Ranking	RPN	Preventive actions to be taken

9.0      Risk identification summary:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

            Sign:

Date:

 

10.0            Risk mitigating tools

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Sign:

Date

 

 

 

 

 

11.0 Risk prevention tools

 

 

 

 

 

 

 

 

 

 

 

 

Sign:

Date:

 

12.0 Deficiency, Corrective and Preventive Action

12.1	Deficiency Observed :
12.2	Corrective action proposed :
12.3	Time Fine for corrective action :
12.4	Evolution  of Corrective action :

 

Sign:

Date:

 

13.0 Risk evaluation summary

 

Sr.No.	Description of Risk	Risk Prevention Proposal	Risk Mitigation Tools	Remarks

 

Sign:

Date:

 

 

14.0    Annexure (s):

 

 

Sr.No.	Annexure No.	Title of Annexure

 

15.0                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Risk assessment final report:

 

 

                       

15.1	SUMMARY :
15.2	CONCLUSION :

Sign:

Date:

15.3	FINAL REPORT APPROVAL:

NAME	DESIGNATION	DEPARTMENT	SIGNATURE	DATE
		PRODUCTION
		QUALITY CONTROL
		PROJECTS / ENGINEERING
		QUALITY ASSURANCE

 

 

 

16.0	REFERENCES :

 

1.0	ISO Risk Assessment Guideline No. 14971
2.0	Environmental Risk assessment Guideline of MHRA-Dec.2006
3.0	GAMP-4  Good Equipments Manufacturing Practice version – 4
4.0	Quality Risk Management, USFDA. Oct.2006