Quality System Requirements

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Quality System Requirements
Food Drug Administration in the
U.S. Copenhagen, Denmark November 4, 2008 John
Wilson, Jr., PhD, MPH Senior Vice President,
Clinical Development
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What, exactly, is a QSR?

• Quality System Approach to Pharmaceutical cGMP
  Requirements?
• ISO Standards?
• ICH?

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ICH Q10

• All appropriate principles will be covered
• Spans the entire life cycle
• Emphasizes continuous improvement

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ICH Q10 Origins

• ICH Q10 originates from several other systems
• ISO
• GMP regulations
• ICH Q8
• ICH Q9

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ICH Q10

• ICH Q10 demonstrates industry and regulatory
  support of an effective pharmaceutical quality
  system to enhance the quality and availability of
  medicines around the world in the interest of
  public health. Implementation of ICH Q10
  throughout the product lifecycle should
  facilitate innovation and continual improvement
• ICH Q10 Introduction

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Q10 Objectives

• Product Realization
• To establish, implement, and maintain a system
  that allows the delivery of products with the
  quality attributes appropriate to meet the needs
  of patients, health care professionals,
  regulatory authorities and other internal and
  external customers.

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Q10 Objectives

• Establish and Maintain a State of Control
• To develop and use effective monitoring and
  control systems for process performance and
  product quality, thereby providing assurance of
  continued suitability and capability of
  processes.

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Q10 Objectives

• Facilitate Continual Improvement
• To identify and implement appropriate product
  quality improvements, process improvements,
  variability reduction, innovations and
  pharmaceutical quality system enhancements,
  thereby increasing the ability to fulfill quality
  needs consistently.

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Management Responsibilities

• Leadership
• essential to establish and maintain a
  company-wide commitment to quality and for the
  performance of the pharmaceutical quality system
• Senior management
• ultimately responsible

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CAPA

• Corrective and Preventive Action
• Pharmaceutical company needs a system for
  implementing corrective actions resulting from
• investigation of complaints
• product rejections
• non-conformances
• A structured approach, with trending studies, is
  appropriate.

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Result

• Continual Improvement
• Ongoing activities to evaluate and positively
  change products, processes and the quality system
  to increase effectiveness
• Joe Famulare FDA
• Gerry Migliaccio Pfizer

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Measures of Success

• Science-based approaches
• Decisions based on understanding of products
  intended use
• Proper identification and control of areas of
  potential process weakness
• Responsive deviation and investigation systems
  leading to timely remediation
• Sound methods for assessing and reducing risk
• Well-defined processes and products, starting
  from development, extending throughout the
  product life Joe Famulare FDA
• Gerry Migliaccio Pfizer

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