SOP Guide for Pharma

SOP for Quality Risk Management for Equipment

SOP for Quality Risk Management for Equipment

Standard Operating Procedure for Quality Risk Management for Equipment

1) Purpose

The purpose of this SOP is to establish procedures for conducting quality risk management (QRM) activities related to equipment used in the manufacturing of dental dosage forms, ensuring that risks associated with equipment operation, maintenance, and validation are identified, assessed, and mitigated.

2) Scope

This SOP applies to all equipment used in the production, testing, and control of dental pastes, gels, and mouthwashes within the pharmaceutical industry, where QRM principles are applied to manage equipment-related risks.

3) Responsibilities

The Quality Assurance (QA) Department is responsible for overseeing QRM activities. Engineering and validation personnel are responsible for conducting risk assessments and implementing risk mitigation strategies. Production supervisors and operators are responsible for following risk control measures during equipment operation.

4) Procedure

4.1 Risk Identification

4.1.1 Identify potential risks associated with equipment operation, maintenance, and validation through systematic review and analysis.

4.1.2 Classify identified risks based on severity, probability of occurrence, and detectability.

4.2 Risk Assessment

4.2.1 Conduct qualitative or quantitative risk assessments to evaluate the impact of identified risks on product quality, patient safety, and regulatory compliance.

4.2.2 Prioritize risks based on assessment results to focus resources on managing high-risk areas.

4.3 Risk Mitigation

4.3.1 Develop risk mitigation strategies

and control measures to reduce or eliminate identified risks to an acceptable level.

4.3.2 Implement risk controls through documented procedures, including equipment design improvements, operational controls, and validation activities.

4.4 Risk Monitoring and Review

4.4.1 Monitor effectiveness of implemented risk controls through ongoing monitoring and periodic review.

4.4.2 Update risk assessments and mitigation strategies as needed based on new information, changes in equipment or processes, or emerging risks.

4.5 Documentation and Reporting

4.5.1 Document all QRM activities, including risk assessments, mitigation plans, and monitoring results.

4.5.2 Prepare periodic reports on QRM activities for review by QA and management.

5) Abbreviations, if any

SOP – Standard Operating Procedure

QRM – Quality Risk Management

QA – Quality Assurance

6) Documents, if any

Risk Assessment Reports

Risk Mitigation Plans

QRM Procedures

QRM Review Reports

7) Reference, if any

ICH Q9: Quality Risk Management guidelines

Company-specific QRM policies and procedures

8) SOP Version

Version 1.0

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