internal audit in pharmaceutical- an essential tool

DISCLAIMER

WHAT IS IN IT??

INTERNAL AUDIT

BENEFITS OF INTERNAL AUDIT

THE AUDIT SCHEDULE

THE TRAINED AUDITOR

MANAGING THE AUDIT

WHAT IS IT ?

Napo in Safe on Site - episode 003 - Heading for a fall - YouTube[via torchb.mp4

PRINCIPLES OF QRM

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?

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

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

RISK ASSESSMENT

Severity (S)

Pro

babi

lity

(P) high

medium

low

risk

Detecta

bility

(D)

RISK ASSESSMENT

RISK CONTROL AND RISK REVIEW

QRM AND INTERNAL AUDIT

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

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”

CONCLUSION

Sharing information

WAY FORWARD