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Quality Systems and Risk Management (Q9 & Q10) Advisory Committee of the Office of Pharmaceutical Science, Center for Drug Evaluation and Research, USFDA October 5, 2006 Frederick Razzaghi CHPA Agenda Introduction Quality Risk Management Q9 Relation of Q9 to Q10 The guidance Next step

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Quality Systems and Risk Management (Q9 & Q10)

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Quality systems and risk management q9 q10 l.jpg

Quality Systems and Risk Management (Q9 & Q10)

Advisory Committee of the Office of Pharmaceutical Science,

Center for Drug Evaluation and Research, USFDA

October 5, 2006

Frederick Razzaghi

CHPA


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Agenda

  • Introduction

  • Quality Risk Management Q9

  • Relation of Q9 to Q10

  • The guidance

  • Next step


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Establishing the science to help settle questions.

(developing the knowledge)

Doing what is important.

(Can we afford to do everything?)


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Doing what is important(Risk based)

  • Non-science and precedence based Requirements have an accumulative effect.

  • Overwhelm organizations.

  • Organizations can not answer the value question!

  • Highlighted in part by the current period of dwindling resources and demand for faster and better outcomes.


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Risk based

Quality Risk Management:

Using established knowledge to determine what is important


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What is Q9

  • Q9 is a systemic process oriented approach to decision making that is intended to be practical, applicable, predictive, flexible, consistent and integrated.

  • The ICH Q9 document:

    • Main body explains the “What?”

    • Annex (I) give ideas on the “How?”

    • Annex (II) give ideas on the “Where?”

  • It is designed to be implemented by industry and regulators

    • Pharmaceutical development (ICH Q8) and Quality Systems (ICH Q10) will facilitate the “What?”, “How?” and “Where?”

  • “It helps to simplify and prevent overly prescriptive and unnecessary requirements.


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What does Q9 offer

  • Quality risk management serves as a foundation to support, other ICH Quality documents and complement best quality practices, requirements, standards, and guidelines within industry and regulators. It specifically provides guidance on the principles and some of the tools of quality risk management to enable consistent risk based decisions across the product lifecycle.


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Reasons for writing Q9

The circumstances affecting regulators & industry

  • Increasing external requirements

  • Increasing demands and costs

  • Growing complexity and scope of risks

    Empowerment & Flexibility

  • Master complexity and streamline decision making

  • Proactive disclosure and build trust and understanding

  • Improve communication through sharingbest practice and science based knowledge

  • Convert data into knowledge


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Reasons for writing Q9

  • Establish a common understanding of Quality Risk Management (QRM) among industry and competent authorities

  • Facilitate moving to the “Desired State”

    • By enhancing communication and transparency

    • Moving from ‘fire fighting’ to proactive management of risk


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Benefits of risk management

  • Enhanced public confidence in decision making on pharmaceutical quality

  • Promotes more effective use of regulator and industry resources

  • Establishes systematic and better-informed decision making.

  • Increases knowledge of risk

  • Fosters quality by design and continuous improvement


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Benefits of risk management

  • Understand the factors that impact regulators and industry operations.

  • Create awareness and a culture

    • Supports pro-active behaviour

    • Open factual dialogue

    • Make decisions traceable and consistent

  • Provide assurance

    • Risks are adequately managed

    • Compliance to external and internal requirements

  • Recognise risks at a desired level

    • Zero risk not possible


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Q9 links back to patient safety

.

Opportunities to impact risk using quality risk management

Design

Process

Materials

Manufacturing

Facilities

Distribution

Patient


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Q9 was constructed using knowledge gained from established standards

  • ISO/IEC Guide 73: 2002 - Risk Management - Vocabulary - Guidelines for use in Standards

  • ISO/IEC Guide 51:1999 - Safety Aspects - Guideline for their inclusion in standards

  • WHO Technical Report Series No 908, 2003 Annex 7 Application of Hazard Analysis and Critical Control Point (HACCP) methodology to pharmaceuticals

  • GAMP Good Practice Guide ISPE, 2005 A risk-based approach to compliant electronic records and signatures

  • ISO 14971:2000 - Application of Risk Management to Medical Devices


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Developing the knowledge:(Science based)

  • The Q documents are a part of the knowledge.

  • Establishing new knowledge

  • Combining basic disciplines & practices

  • Core: Engineering, Pharmaceutical sciences,

  • Gap: Technology, Economics, Management (risk, ….)


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Q9 integrated into Q10


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ICH Q documents

  • Q1 Stability

  • Q2 Analytical Validation

  • Q3 Impurities

  • Q4 Pharmacopoeias

  • Q5 Quality of Biotechnological Products

  • Q6 Specifications

  • Q7 Good Manufacturing Practice

  • Q8 Pharmaceutical Development

  • Q9 Quality Risk Management

  • Q10 Pharmaceutical Quality Systems


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Q9 enables quality systems to address the following problems

  • Product may not be available to patients

  • Increase the potential for release of unacceptable product

  • Delay in new product introductions

  • Delays in the implementation of changes and improvements

  • Recall of drugs

  • Inefficient allocation of resources


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Q8, Q9 and Q10 are aligned with the new approach

  • GMP Workshop in July 2003: 5 year vision:

    “Develop a harmonised pharmaceutical quality system applicable across the life cycle of the product emphasizing an integrated approach to quality risk management and science”

  • Consequent ICH Expert Working Groups (EWG):

    • ICH Q8, on Pharmaceutical Development, doc. approved Nov. 2005

    • ICH Q9, on Quality Risk Management, doc. approved Nov. 2005

    • ICH Q10, on Quality Systems, topic accepted 2005


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How Q9 interacts with Q8 and Q10

envision

Risk from Manufacturing site

High

Q10 Pharm. Quality Systems

Low

Q8 Pharmaceutical Development

Low

High

Product / Process Risk


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New Q distinctions

Pharmaceutical Development (Q8)Past:Data transfer / Variable output

Present:Knowledge transfer / Science based / Consistent output

Quality Risk Management (Q9)

Past:Used, however poorly defined

Present:Opportunity to use structuredprocess and integrated thinking

Pharmaceutical Quality Systems (Q10)Past:GMP checklist

Future:Quality Systems across product life cycle


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New Q distinctions


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The Guidance

  • Process

  • Formula

  • Relationship to uncertainty

  • Tools

  • Application & integration


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Initiate

Quality Risk Management Process

Risk Assessment

Risk Identification

Risk Analysis

Risk Evaluation

unacceptable

R

i

n

s

o

k

i

t

a

M

Risk Control

c

a

i

n

n

a

u

g

Risk Reduction

m

e

m

m

o

e

C

n

t

k

t

Risk Acceptance

s

o

i

o

R

l

s

Output / Result of the

Quality Risk Management Process

Risk Review

Review Events

The process


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Dimensions of a risk based approach

.

Parameters for evaluating risks

high

probability

medium

detectability

low

risk

severity


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Risk and Uncertainty

.

Tomorrow ?

Upper Specification Limit (USL)

Process Parameter 

Lower Specification Limit (LSL)

Time

today

RISK: Control options are scenarios for risk management. Note that this scenario shows the best estimate is below the USL.


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Risk and uncertainty

  • Components of uncertainty:

  • Limitations of human knowledge

  • Absence of established science.

  • Limitations of Technology


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Some Risk assessment tools

  • Failure Mode & Effects Analysis (FMEA)

  • Failure Mode, Effects and Criticality Analysis (FMECA)

  • Fault Tree Analysis (FTA)

  • Hazard Analysis of Critical Control Points (HACCP)

  • Hazard Operability Analysis (HAZOP)

  • Preliminary Hazard Analysis (PHA)

  • Risk ranking and filtering


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Application & Integration


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Q9 applies across the lifecycle

.

Research

Preclinical Phase

Clinical Phases

Launch

Manufacturing & Distribution

Safety

GLP

GCP

Efficacy

GMP

Quality

ICH Q9

GDP


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Integrating QRM into product life cycle

Gain experience

Analyse root cause:

Continuous improvement

(Risk of) Failure ?

Manufacture

Quality Risk Management(QRM)

Improve it

Do, what you say

Update information

Approval

Say, what you do


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Integration into operations: industry & regulators

  • Foundation for “science-based” decisions

  • Degree of rigor and formality commensurate with the complexity and/or criticality of the issue

  • Implement QRM principles when updating existing guidelines


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Regulatory operations

Inspection and assessment activities

Internal systems

Industry operations

Development

Facilities, equipment and utilities

Materials management

Production

Laboratory control and stability testing

Packaging and labelling

Application


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Application

  • Integrated quality management

    • Documentation

    • Training and education

    • Quality defects

    • Auditing / Inspection

    • Periodic review

    • Change management / change control

    • Continual improvement


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Application

  • Quality risk management is intended to enable and enhance compliance with regulatory requirements and science-based decisions when integrated into quality systems.

  • It is also meant to be applied where it is practical and feasible.


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Implementation of Q9 can help identify weak links


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Definitions

  • Quality: Degree to which a set of inherent properties of a product, system or process fulfills requirements

  • Risk: combination of the probability of occurrence of harm and the severity of that harm

  • Quality Risk management: Systematic process for the assessment, control, communication and review of risks to the quality of the drug (medicinal) product across the product lifecycle


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Way Forward

  • Review

  • Implementation


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Implementation

  • Work to Adapt existing structures, organizations and systems

    • Raise awareness of rationales for decision making

    • Education: Develop training

    • Do not create new requirements


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Implementation

  • Work to Improve communication and transparency

  • More specific projects: (e.g. DMF’s)

  • Academic collaborations


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Review and determine gaps

  • Examine need for additional guidance: (e.g. Excipients, Packaging/Distribution)

  • Adapt and update existing requirements using quality risk management


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Thank you


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