INTERNAL AUDIT IN PHARMACEUTICAL- AN ESSENTIAL TOOL
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Transcript of INTERNAL AUDIT IN PHARMACEUTICAL- AN ESSENTIAL TOOL
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DISCLAIMER
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WHAT IS IN IT??
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INTERNAL AUDIT
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BENEFITS OF INTERNAL AUDIT
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THE AUDIT SCHEDULE
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THE TRAINED AUDITOR
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MANAGING THE AUDIT
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WHAT IS IT ?
Napo in Safe on Site - episode 003 - Heading for a fall - YouTube[via torchb.mp4
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PRINCIPLES OF QRM
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TYPICAL QRM PROCESS
Risk Review
Ris
k C
om
mu
nic
atio
n
Risk Assessment
Risk Evaluationunacceptable
Risk Control
Risk Analysis
Risk Reduction
Risk Identification
Review Events
Risk Acceptance
InitiateQuality Risk Management Process
Output / Result of theQuality Risk Management Process
Risk M
anage
ment tools
• 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?
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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
CriticalSerious GMP non-compliancePatient injury possible
ModerateSignificant GMP non-complianceImpact on patient possible
MinorMinor GMP non-complianceNo patient impact
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RISK ASSESSMENT
Risk = P x SSeverity
Probability Minor Moderate Critical
HighUnacceptable risk
Intolerable risk Intolerable risk
MediumAcceptable risk Unacceptable risk Intolerable risk
LowAcceptable risk Acceptable risk Unacceptable
risk
Remote Acceptable risk Acceptable risk Acceptable risk
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RISK ASSESSMENT
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Severity (S)
Pro
babi
lity
(P) high
medium
low
risk
Detecta
bility
(D)
RISK ASSESSMENT
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RISK CONTROL AND RISK REVIEW
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QRM AND INTERNAL AUDIT
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CONCERNS
?Increasing external requirementsfor 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 uncertaintyIncreasing
efforts and costs for sustainability. E.g documentation, projects, Systems
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QRM THROUGH INT. AUDIT
Proactive disclosure
build trust and understanding
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
NOVEL APPROACHES FOR QRM THROUGH “INT. AUDIT”
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CONCLUSION
Sharing information
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WAY FORWARD
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