Transcript The Pharmaceutical Industry and ICH Q9 Peter H Gough Partner, David Begg Associates 21st Century GMP Initiative “Seeks to integrate quality systems and risk management approaches.

The Pharmaceutical Industry
and ICH Q9
Peter H Gough
Partner, David Begg Associates
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21st Century GMP Initiative
“Seeks to integrate quality systems and risk
management approaches into the existing
programmes and encourages adoption of modern
and innovative manufacturing technology.”
“Use existing and emerging science and analysis to
ensure that limited resources are best targeted to
address important quality issues, especially those
associated with predictable or identifiable health
risks.”
Lester M. Crawford, FDA Deputy Commissioner,
21 August 2002
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FDA’s “Desired State”
 Regulatory policies tailored to recognise
the level of scientific knowledge
supporting applications, process validation
and process capability
 Risk-based scrutiny related to:
 Level of scientific understanding
 Capability of process control strategies to
prevent or mitigate risk of producing a poor
quality product
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International Conference on
Harmonisation (ICH)
 EU and Japan joined USA to
define a new paradigm at an
ICH GMP Workshop in Brussels,
July 2003
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ICH – Structure and Members
Expert Working
Groups (EWGs)
Q uality
S afety
E fficacy
M ultidisciplinary
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ICH GMP Workshop
 ICH GMP Workshop in Brussels, July 2003
 This Workshop agreed a 5 year Vision:
 Create a single, harmonised global quality
standard and interpretation based on good
science and risk management principles
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Incremental Steps to Achieve the
Vision
 The GMP Workshop agreed that the Vision
would be achieved by ‘incremental steps’:
 Q8 EWG, on Pharmaceutical Development,
established in September 2003
 Q9 EWG, on Quality Risk Management,
established in November 2003
 Q10 EWG, on Pharmaceutical Quality
System, established in November 2005
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Achieve by Incremental Steps
Pharmaceutical Development (Q8)
Changed
Paradigm
Old:
New:
Data transfer / variable output
Knowledge transfer /
Consistent output
Quality Risk Management (Q9)
Old:
New:
Unstructured approach
Opportunity to use a structured
process
Quality Systems (Q10)
Q9
Old:
New:
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Large variability on Q-systems
Consistency on Q-systems
Risk Management
 We all do risk management every day
 Driving to work
 Extreme sports
 Everything in life has some degree of risk
 Can NEVER have zero risk
 We all manage risk but we have different
risk thresholds
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Risk and Management
If you do not manage risk;
it will manage you.
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What is Risk Management?
PROACTIVELY:
 Identifying risks (what can go wrong?)
 Analysing risks
 Evaluating risks
 Controlling and reducing these risks
 Accepting residual risk
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Pharmaceutical Industry and Risk
Management


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Pharmaceuticals have lagged behind related
industries in adopting formal risk management,
e.g.

Medical devices, ISO 14971

Food, HACCP
We are using risk management but historically

Implementation was patchy

It was often not fully integrated with rest of the
Quality System

Was performed retrospectively
Quality Risk Management
 Pharmaceutical Quality Risk
Management is about:
 Knowing your processes (manufacturing
and business)
 Identifying what’s truly important
 Focusing your money, time, energy and
people on the things that are really
important, i.e. things which have potential
to impact patients
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Advantages of Risk Management
 Systematic, scientific and data-driven
process
 Reduces subjectivity
 Ranks risk - allows prioritisation
 Improves decision making
 Identifies what gives most benefit to the
patient
 Documented - improves communication
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Risk Management
 Must do risk management properly
 Poor risk management will not impress
regulators

They will think we do not know what’s really
important

If everything is critical, nothing is critical
 Ultimately, it is about credibility
 Have to begin with the question “What is the
impact on the patient?”
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Why Did We Need ICH Q9 ?
 Needed ICH Q9 to:
 Explain what quality risk management is
and how it can be applied to
pharmaceuticals
 Provide a common language and an
agreed process for the pharmaceutical
industry and regulators
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Why Did We Need ICH Q9?
 To ensure both industry and regulators
have common understanding of
Quality Risk Management (QRM)
 To facilitate moving to the ‘Desired State’
 To facilitate communication and
transparency
 To move from ‘fire fighting’ to
management of risk
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ICH Q9 Definitions
Harm =
damage to health, including the
damage that can occur from loss of
product quality or availability
Hazard = potential source of harm
Risk =
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combination of probability of harm
and severity of that harm
What Does ICH Q9 Deliver?
 ICH Q9 provides:
 The key principles of QRM
 A common language and process
 Potential methodologies for QRM
 Potential applications where QRM can
add value
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ICH Q9 – Principles of Quality
Risk Management
Two primary principles:
 1. The evaluation of the quality risk
should be based on scientific knowledge
and ultimately link back to the protection
of the patient
 2. The level of effort, formality and
documentation of the quality risk
management process should be
commensurate with the level of risk
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ICH Q9 Quality Risk Management
Process
Initiate
Quality Risk Management Process
Risk Assessment
Risk Identification
Risk Evaluation
Risk Control
Risk Reduction
Risk Acceptance
Output / Results of the
Risk Management Process
Risk Review
Review Events
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unacceptable
Risk Management Tools
Risk Communication
Risk Analysis
ICH Q9 – Annex 2
Potential Applications for Quality
Risk Management
 To provide a comprehensive evaluation of
suppliers and contract manufacturers
(e.g., auditing, supplier quality
agreements)
 To provide information for ensuring the
availability of pharmaceuticals (e.g.,
ranking risks to the supply chain)
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Supply Chain Risks
 Recent events have exposed several areas
of risk:
 Heparin contamination is USA and elsewhere
 Melamine contamination of milk in China
 Further cases of diethylene glycol
contamination of glycerol
 Counterfeit products entering the legitimate
supply chain in the EU
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Supply Chain Risks
 These supply chain risks are real
 Probably rank amongst the highest hazards
currently faced
 The must be managed proactively
 ICH Q9 and this PQG Guide provide an
excellent approach
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PQG Supply Chain Risk
Management
 When we wrote Q9 we hoped it would
encourage greater understanding of risk &
risk management in the pharmaceutical
industry
 This PQG Guide is exactly the type of
detailed thinking that we hoped to see
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Watch Out !
 To add value QRM must be done properly
 You must have the right experts on your
team
 You must consider all reasonable hazards
 You must use the right weightings for
hazards
 Ultimately it must be about the patient
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Watch Out !
FMEA Risk Priority Numbers
 The absolute number is unimportant
 RPN allows risks to be ranked
 Allows action to be prioritised
 Provides justifiable basis for decision
making… including doing nothing!
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Conclusion
 We are already doing Quality Risk
Management
 Using a structured, systematic process adds
value in many more complex situations
 Supply Chains are complex!
 The PQG Guide provides a good framework
 Use it pro-actively
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Thank you
David Begg Associates
www.DBA-global.com
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