molecule-to-market-place quality dawn sanchez-barona, phd senior director, quality control quality...
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Molecule-to-Market-PlaceMolecule-to-Market-PlaceQualityQuality
Dawn Sanchez-Barona, PhDSenior Director, Quality Control
Quality OperationsEisai Inc.
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OverviewOverview 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
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ReferencesReferences
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
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Role of Quality OperationsRole 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.
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Principles of Quality ManagementPrinciples 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 company’s 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.
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Example of Quality Operations Example of Quality Operations OrganizationOrganization
Manufacturing QA
QC
Validation
Clinical QA
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Responsibilities – Manufacturing QAResponsibilities – 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
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Responsibilities – QCResponsibilities – 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
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Responsibilities – ValidationResponsibilities – 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
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Responsibilities – Clinical QAResponsibilities – 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.
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Quality
Manufacturing QA
Validation QC
Clinical QA
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Quality Operations in Pharmaceutical and Analytical
Development
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The New Drug Development ProcessThe New Drug Development ProcessSteps from Test Tube to New Drug Application ReviewSteps from Test Tube to New Drug Application Review
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Quality Operations in Pharmaceutical Quality Operations in Pharmaceutical and Analytical Developmentand 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.
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Responsibilities – Manufacturing QAResponsibilities – 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
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Responsibilities – Responsibilities – Analytical DevelopmentAnalytical 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
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Responsibilities – ValidationResponsibilities – 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
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Quality Strategy in Pharmaceutical Quality Strategy in Pharmaceutical DevelopmentDevelopment
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
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BackgroundBackground
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
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BackgroundBackground
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.
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Establishing Design Space: GainsEstablishing 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
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Establishing Design Space: Establishing Design Space: Challenges 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!
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