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INTERNAL AUDIT IN PHARMACEUTICAL- AN ESSENTIAL TOOL
The document discusses quality risk management (QRM) and its relationship to internal auditing. It outlines the typical QRM process, including risk identification, analysis, evaluation, control, communication and review. It notes that QRM can help address growing complexity, scope of risks, and external compliance requirements. The document proposes that QRM and internal auditing should be integrated to help organizations more efficiently meet requirements, improve communication, and master complexity through sharing of best practices and knowledge.
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INTERNAL AUDIT IN PHARMACEUTICAL- AN ESSENTIAL TOOL
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- 4. WHAT IS INIT??
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- 8. BENEFITS OF INTERNALAUDIT
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- 14. WHAT IS IT? Napo in Safe on Site - episode 003 - Heading for a fall - YouTube[via torchb.mp4
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- 16. TYPICAL QRM PROCESS RiskReview RiskCommunication Risk Assessment Risk Evaluation unacceptable Risk Control Risk Analysis Risk Reduction Risk Identification Review Events Risk Acceptance Initiate Quality Risk Management Process Output / Result of the Quality Risk Management Process RiskManagementtools • What might go wrong or has gone wrong? • What is likelihood or probability? • What are the consequences (severity)? • What is the level of risk? Any mitigating factors?
- 17. RISK ASSESSMENT P –Probability of Occurrence High Likely to occur Medium May occur Low Unlikely to occur Remote Very unlikely to occur S – severity level if event occurs Critical Serious GMP non- compliance Patient injury possible Moderate Significant GMP non- compliance Impact on patient possible Minor Minor GMP non- compliance No patient impact
- 18. RISK ASSESSMENT Risk =P x S Severity Probability Minor Moderate Critical High Unacceptable risk Intolerable risk Intolerable risk Medium Acceptable risk Unacceptable risk Intolerable risk Low Acceptable risk Acceptable risk Unacceptable risk Remote Acceptable risk Acceptable risk Acceptable risk
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- 21. RISK CONTROL ANDRISK REVIEW
- 22. QRM AND INTERNALAUDIT
- 23. CONCERNS ? Increasing external requirements for best practice, transparencyand compliance • Public / Community • Governments • Regulators • Investors / Creditors Increasing external requirements for best practice, transparency and compliance • Public / Community • Governments • Regulators • Investors / Creditors Growing complexity and Scope of risks • Globalisation “Multinational” • Multi-factor approaches • Regulatory expectations • Acceptance of risk and uncertainty Growing complexity and Scope of risks • Globalisation “Multinational” • Multi-factor approaches • Regulatory expectations • Acceptance of risk and uncertainty Increasing efforts and costs for sustainability. E.g documentation, projects, Systems Increasing efforts and costs for sustainability. E.g documentation, projects, Systems
- 24. QRM THROUGH INT. AUDIT QRM THROUGH INT. AUDIT Proactive disclosure buildtrust and understanding Proactive disclosure build trust and understanding Improve communication through sharing best practice and science based knowledge Improve communication through sharing best practice and science based knowledge • An appropriate integrated approach helps to meet requirements more efficiently Master complexity Convert data into knowledge e.g. by using methodology and tools Master complexity Convert data into knowledge e.g. by using methodology and tools NOVEL APPROACHES FOR QRM THROUGH “INT. AUDIT”
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