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SOP for Quality Risk Management

Standard operating procedure for quality risk assessment and quality risk management (QRM) in pharmaceuticals.

1.0 OBJECTIVE:
To lay down the procedure for Quality Risk Management.

2.0 SCOPE:
This procedure shall be applicable to Product, Process, Equipment, Systems.

3.0 RESPONSIBILITY:
All Department Heads

4.0 ACCOUNTABILITY:
All Department Heads

5.0 PROCEDURE:

5.1 Quality Risk Management

Quality Risk Management is a systematic process for the assessment, control, communication and review of risks to the quality of the drug (medicinal)
product across the product lifecycle.
The two primary principles of Quality Risk Management are:
1. the evaluation of the risk to quality should be based on scientific knowledge and ultimately link to the protection of the patient and
2. the level of effort, formality and documentation of the Quality Risk Management process should be commensurate with the level of risk.

Risk Assessment:
The Risk Assessment consists in the identification of hazards, analysis and evaluation of risks associated with exposure to those hazards Risk assessment
defines with three fundamental questions.
a) Risk Identification address what might go wrong.
b) Risk analysis, to analyze the risk involved.
c) Risk evaluation, comparing the risk identification and analyze the risk against the criteria.
Any potential risk identified shall be assessed qualitatively and quantitatively. The risk assessment shall be done in a cross functional committee to read
upto a common rating.
The output of risk is measured in two ways:
1. Qualitatively: The risk shall be categorized into “High” “Medium” and “Low”.
2. Quantitatively: The risk shall be provided with numerical values “1” “2” “3” “4” and “5”.

Severity of risk shall be categorized as:

Category Description Score
Critical Very significant and having catastrophic impact on product 1
High Significant losses and require timely addressal management intervention required. 2
Moderate Loss of operating capability, long term of problem causes adverse effect. 3
Minor Impact on operations and efficiency, but limited effect. 4
Insignificant Very minor or no impact on operations and quality of operational efficiency. 5

Likelihood of risk shall categorized as:

Based on the discussion / view of the user department & QA/QC head.
Category Description Score
Almost certain Is expected to occur in most circumstances 1
Likely Will probably occur in most circumstances 2
Possible Will probably occur at some time 3
Unlikely Could occur at some time 4
Rare May occur in exceptional circumstances 5

Risk Control:
Risk Control analyzes and categorize accordingly.
Control of risk divided into:
Risk Reduction by different measures opted and elaborated in risk Management document.
Risk Acceptance, as the risk involved is up to the acceptable level.
Control Mitigation control of risk shall categorize as:
 Category Description Score
Insufficient information to adequately
Not aware 1
assess and rate the control
Non existent No mitigation plans in place 2
Mitigation plans though in place do not
Not effective ensure adequate control over risk 3
occurrence / impact.
Mitigation plans involve is effective against
the identified risk of HVAC, although
Effective chances of occurrence minimize, but there 4
is very less possibility of occurrence of
identified risk.
Mitigation plans involve high degree of
Very Effective control on the operational procedure and is 5
effective against all identified risk.

Procedure for mitigation shall explained in the respective protocol.

Risk mitigation plan shall be discussed amongst the cross functional departmental heads and an appropriate measures to mitigate the risk be used.
On the basis of qualitative and quantitative status risk shall categorize into:

RISK LEVEL OBTAINED SCORE

HIGH RISK 3 to 6
MEDIUM RISK 7 to 11
LOW RISK 12 to 15

Sr.No. Risk
Quantitative Qualitative
Identification Risk Involved Remarks
Score Status
No.

Risk Identification number shall provide as R001, R002 … so on, for the risk management protocol, and the severity, likelihood and mitigation of risk shall
be evaluated on the basis of qualitative and quantitative means.

Identified Risk with severity, likelihood and mitigation shall club together to provide the overall picture of risk assessment.

Quantitative
Identification
Analyzing Evaluation Risk Evaluation Qualitative
of Risk
Risk
the Risk of Risk Reduction Evaluation
Involved
Sr. Identification

No Description Total Score No.

Severity Mitigation
Likelihood Risk
of Risk Plan
Risk Category
Impact (Control)

Interdisciplinary teams are formed to undertake the activity of QRM, they should include experts from the appropriate areas (e.g. QA, QC, Production,
Regulatory Affairs, Engineering, stores, Marketing, Legal, etc.) in addition to individuals who are knowledgeable about the QRM process.

As after Categorize the risk, evaluate the individual risk, and execute the corrective and preventive action, as per the High, Medium and Low risk.
Risk Category: High, Medium and Low.
 Risk ID. No. Total Score Corrective action Preventive action Responsibility Remarks

Risk Review:
The appropriate quality indicators like Change Control, Deviations and CAPA procedures shall followed to execute the QRM (Quality Risk Management).
Risk Communication:
Training shall provide to all concerns between the decision makers and the actual executors:
Also see: Quality Risk Management in Pharmaceuticals

Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical
blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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