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MoleculetoMarketPlace Quality

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Ensure (Eisai) patients receive clinical or commercial products that are safe, ... Clinical QA. Broadly responsible for ensuring clinical trials ... – PowerPoint PPT presentation

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Title: MoleculetoMarketPlace Quality


1
Molecule-to-Market-PlaceQuality
  • Dawn Sanchez-Barona, PhD
  • Senior Director, Quality Control
  • Quality Operations
  • Eisai Inc.

2
Overview
  • Role of Quality Operations
  • Principles of Quality Management
  • Example of Quality Operations Organization
  • Responsibilities of Each Quality Department
  • Quality Operations in Pharmaceutical and
    Analytical Development
  • Quality Strategy in Pharmaceutical Development

3
References
  • Q7A Good Manufacturing Practice Guide for
    Active Pharmaceutical Ingredients
  • Q8 Pharmaceutical Development
  • Q9 Quality Risk Management
  • The Gold Sheet, Vol. 40, August 2006
  • www.ich.org
  • www.FDA.gov/cder/handbook/development.htm

4
Role of Quality Operations
  • Ensure (Eisai) patients receive clinical or
    commercial products that are safe, pure, and fit
    for their intended use, and comply with all
    regulatory requirements.

5
Principles of Quality Management
  • All persons involved in manufacturing
    pharmaceutical products are responsible for
    quality.
  • Each manufacturer should establish, document, and
    implement an effective system for managing
    quality that requires the commitment and active
    participation of management and staff at all
    levels in the company as well as the companys
    suppliers, contractors, and distributors.
  • There should be a quality unit(s) that is
    independent of production and that fulfills the
    quality assurance (QA) and quality control (QC)
    responsibilities.
  • Quality-based decisions are based on sound
    scientific judgment and evaluation and require
    defined processes to implement.

6
Example of Quality Operations Organization
7
Responsibilities Manufacturing QA
  • Broadly responsible for implementation and
    adherence to GMPs, product disposition, and
    quality systems associated with these functions
  • Document Control
  • Auditing/Vendor Certification
  • Training
  • Product Dispositions
  • Deviations/Investigations/Corrective
    Actions/Preventative Actions
  • Change Control
  • Label Review and Disposition
  • Reserve/Retain Sample Management
  • Complaints
  • Trending
  • Annual Product Reviews
  • Contract Manufacturing Organizations

8
Responsibilities QC
  • Broadly responsible for laboratory controls
    associated with product disposition and quality
    systems required for this function
  • Sampling/Disposition Raw Materials and Packaging
    Components
  • GMP Laboratory Management
  • Release Testing
  • Stability Testing and Program Management
  • Document Control/Evaluation
  • Out-of-Specification Investigation
  • Reference Standard Management
  • Analytical Technology Transfer/Validation
  • Analytical Evaluation of Post-Market Changes
  • Investigation Support

9
Responsibilities Validation
  • Broadly responsible for establishing a
    validation program and compliant documentation
    and execution of all qualification and validation
    activities, including
  • Equipment Qualification
  • Computer System Validation
  • Cleaning Validation
  • Process Validation
  • Periodic Review of Validated Systems
  • Risk Assessment

10
Responsibilities Clinical QA
  • Broadly responsible for ensuring clinical trials
    are conducted in accordance with GCPs, and that
    data are generated, documented, and reported
    accurately and in compliance with all applicable
    regulatory requirements.

11
Quality
Clinical QA
Manufacturing QA
QC
Validation
12
  • Quality Operations in Pharmaceutical and
    Analytical Development

13
The New Drug Development ProcessSteps from Test
Tube to New Drug Application Review
14
Quality Operations in Pharmaceutical and
Analytical Development
  • Goals are same i.e, role of Quality Operations
    and principles of Quality Management does not
    change.
  • Tactics for implementing quality can be
    different.
  • Controls used in the manufacture of active
    pharmaceutical ingredients (APIs) and drug
    products should be consistent with the stage of
    development.
  • Process and test procedures should be flexible to
    provide for changes as knowledge of the process
    increases, and clinical testing of a drug product
    progresses from pre-clinical through clinical
    stages.

15
Responsibilities Manufacturing QA
  • Broadly responsible for implementation and
    adherence to GMPs, product disposition, and
    quality systems associated with these functions
  • Document Control
  • Auditing/Vendor Certification
  • Training
  • Product Dispositions
  • Deviations/Investigations/Corrective
    Actions/Preventative Actions
  • Change Control
  • Label Review and Disposition
  • Reserve/Retain Sample Management
  • Complaints
  • Trending
  • Annual Product Reviews
  • Contract Manufacturing Organizations

16
Responsibilities Analytical
Development
  • Testing functions commonly performed by QC can
    be performed within other organizational unit,
    such as Analytical Development (AD).
  • In this example, AD would be broadly responsible
    for laboratory controls associated with clinical
    product disposition and quality systems required
    for this function
  • Sampling/Disposition Raw Materials and Packaging
    Components
  • GMP Laboratory Management
  • Release Testing
  • Stability Testing and Program Management
  • Document Control/Evaluation
  • Out-of-Specification Investigation
  • Reference Standard Management
  • Analytical Technology Transfer/Validation
  • Analytical Evaluation of Post-Market Changes
  • Investigation Support

17
Responsibilities Validation
  • Broadly responsible for establishing a
    validation program and compliant documentation
    and execution of all qualification and validation
    activities, including
  • Equipment Qualification
  • Computer System Validation
  • Cleaning Validation
  • Process Validation
  • Periodic Review of Validated Systems
  • Risk Assessment

18
Quality Strategy in Pharmaceutical Development
  • Theme Quality by Design (QbD)
  • Knowledge of process (design space)
  • Identification of steps critical to quality of
    drug substance or drug product
  • Control strategies for synthesis/formulation
    choices justified

19
Background
  • PD Goal Design a quality product and
    manufacturing process to consistently deliver the
    intended performance of the product.
  • Information and knowledge gained from
    pharmaceutical development studies provide
  • Scientific basis for establishing the formulation
    design space, specifications, and manufacturing
    controls
  • Rationale for quality risk management

20
Background
  • Design Space
  • Multidimensional combination and interaction of
    input variables (e.g., material attributes) and
    process parameters that have been demonstrated to
    provide assurance of quality.
  • Proposed in (NDA) filing and subject to
    regulatory (FDA) assessment.
  • Working within design space not considered a
    change.
  • Movement out of design space considered a change
    and would initiate a typically regulatory
    post-approval filing.

21
Establishing Design Space Gains
  • Creates higher degree of understanding of
    material attributes, manufacturing processes and
    their controls within your company and with FDA.
  • Facilitates understanding of differences between
    the manufacturing processes used to make drug
    product for pivotal clinical trials/stability
    studies and vs. commercial product
  • Provides potential opportunities for risk-based
    regulatory decisions (reviews and inspections)
  • Facilitates manufacturing process improvements
    without further regulatory review (if stay within
    design space) and may reduce number of
    post-approval submissions
  • Provides potential for real-time quality control
    and reduction of end-product (QC) release testing

22
Establishing Design Space Challenges
  • Establishing appropriate/expected level of detail
    in regulatory submissions
  • Establishing balance between QbD-based vs.
    traditional demonstration of quality
  • Achieving regulatory flexibility while assuring
    product quality
  • Sharing proprietary information with FDA
  • FDA pilot program more work to be done!

23
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