Workshop: Review and Technical Issues for Drug Substances
Sponsor: |
American Association of Pharmaceutical Scientists (AAPS) |
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Chinese Medicine Education Association (CMEA) |
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Organizer: |
AAPS PPB International Outreach Committee |
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American Chinese Pharmaceutical Association (ACPA) |
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Beijing CANNY Consulting Inc. (BCC) |
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I. Target Audiences
Professionals from R&D, Quality Control, Quality Assurance and Regulatory Affairs in pharmaceutical companies and research institutes; Professionals in the area of research and management from universities and regulatory organizations.
II. Objectives
Upon the completion of this workshop, the audiences should gain a good understanding and learn the best practices in the following areas:
Concept of quality by design (QbD) and its application in the research and development of drug substances
Application of risk-assessment, design of experiment and other methods to identify critical quality attributes, critical material attributes, critical process parameters, and the relationships among these attributes
Current review focuses for the Drug Master File (DMF) from the US FDA
Incorporation of QbD elements in the question-based review of DMFs by the US FDA
Technical recommendations for the stability of drug substances and products
Effective quality control of the drug substances according to their structures and synthetic routes
Effective control of the degradant level in drug products through the understanding of the stability and degradation pathways of drug substances
Quality analysis of drug substances
At the end of the workshop, AAPS/CMEA certificates will be awarded to the participants upon successful evaluation.
III. Program content
Overview of Drug Master File (DMF)
CTD format and related requirements for DMFs
Current FDA regulations, review practices and new focuses for DMFs
Manufacturing and physicochemical characterization of drug substances
Manufacturing process of drug substances
Technical requirements for structure elucidation (including polymorphism)
Stability of drug substances: Under accelerated conditions and elucidating degradation pathways
Compatibility of drug substances and excipients
Impact of drug substance on drug product quality: efficacy, safety, and manufacturability
Establishment of quality specifications and control of drug substances
Chirality
Polymorphism
Particle size and distribution
Origin of residual solvents, their classification/limits, and corresponding justifications
Process impurities and degradants in drug substances and finished drug products, including their identification and specifications
ICH reporting threshold, identification threshold and qualification threshold for impurities in drug substances and products based on the maximum daily dose
Strategies to cope with unidentified impurities above the identification threshold, and identified impurities above the qualification threshold
Technical requirements for analytical methods (e.g., impurity and residual solvents) and their validation, and case studies
Technical requirements for drug substance specifications
Application of QbD in the establishment of quality profiles for drug substance
Analytical methods development and validation
ICH/FDA recommendations for different analytical methods
Validation of analytical methods for assay, impurities and residual solvents, including linearity, range, acceptance criteria, reports (e.g., tables, descriptions, and chromatograms)
Source and requirements for reference standards, working standards and impurity standards
Source, identification and purity of the primary reference standards
Source and specifications for the working standards
Source, identification and specifications for the impurity standards
Case studies
IV. Speakers
Haitao Li, Ph.D.: CMC reviewer, FDA
Bingyan Wu, Ph.D.: CMC reviewer, FDA
Lian Yu, Ph.D.: Professor, University of Wisconsin ‒ Madison
Geoff G. Z. Zhang, Ph.D.: Senior Research Fellow, AbbVie
Huyi Zhang, Ph.D.: CMC reviewer, FDA
V. Time: Three days (May 24-26, 2013)
VI. Location: Hilton Hotel, 620 Perry Pkwy Gaithersburg, MD 20877