Guidance and Case Studies

    Key QbD Guidance Documents

    ICH Q8(R2): Pharmaceutical Development

    ICH Q9: Quality Risk Management

    ICH Q10: Pharmaceutical Quality System

    ICH Q11: Development and Manufacture of Drug Substances

    FDA: Pharmaceutical cGMPs for the 21st Century – A Risk-Based Approach

    FDA:  PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance

    FDA: Quality Systems Approach to Pharmaceutical CGMP Regulations

    FDA: Process Validation: General Principles and Practices (Final Guidance)

    Industry Case Histories and Related Materials

    “ACE Tablets” Pharmaceutical Development Case Study

    A-Mab: A Case Study in Bioprocess Development

    “Sakura Tablet” Case Study Materials (NIHS, Japan)

    Goals and Status of Mock Submission Document on Monoclonal Antibodie Products by EFPIA

    EFPIA Draft Mock P2 Document for “Examplain” Hydrochloride (2006)

    A Guide to EFPIA’s “Mock P2″ Document

    PQLI Application of Science- and Risk-based Approaches to Existing Products

    Quality by Design for ANDAs: An Example for Modified Release Dosage Forms

    Quality by Design for ANDAs: An Example for Immediate-Release Dosage Forms

    Related Resources

    ICH Quality Implementation Working Group Training Materials

    ICH Points to Consider Documents 1 (June 2011)

    ICH Points to Consider Documents 2 (December 2011)

    Q8, Q9, and Q10: Questions and Answers (FDA)

    Q8, Q9, and Q10: Questions and Answers (EMA)

    Quality Risk Management: Frequently Asked Questions

    PIC/S Aide Memoire: Assessment of Quality Risk Management Implementation

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