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Pharmaceutical “Quality by Design” (QbD): An Introduction, Process Development and Applications

Pharmaceutical “Quality by Design” (QbD): An Introduction, Process Development and Applications

    AskAboutValidation.com posted a really great  Quality by Design overview piece in late 2012.

    The piece includes:

    • A definition of QbD
    • Bullet point list of the QbD development process
    • Comparison of traditional approaches versus enhanced QbD approaches
    • Understanding of the advantages of QbD

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    Special Report: Hitting the Bull’s Eye with QbD

    Special Report: Hitting the Bull’s Eye with QbD

      For some companies, the concept of Pharmaceutical Quality by Design (QbD) has merely articulated the way they’ve always developed drugs. For others, it has challenged them to take a multidisciplinary approach, and to consider quality and manufacturability from the earliest stages in development.

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      PAT, QbD and Process Validation – The Enablers of Pharmaceutical Quality

      PAT, QbD and Process Validation – The Enablers of Pharmaceutical Quality

        This presentation delivered by Vibhaker Shah, Ph.D., FDA Senior Policy Advisor, is a great reference resource on the merits of QbD, PAT and their links to the fairly new Process Validation guidance.

        Click to view slides

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        White Paper: Effective ICH Q8 Pharmaceutical Development Reports

        White Paper: Effective ICH Q8 Pharmaceutical Development Reports

          The International Conference on Harmonization (ICH) Common Technical Document (CTD) format is the submission standard for new and abbreviated drug product applications in the United States, the European Union and Japan. One of the significant sections of the CTD is the Pharmaceutical Development Report (PDR). A complete PDR is essential to provide a comprehensive understanding of the product and process for the FDA application reviewers and inspectors. The information in the PDR is based upon the documentation generated during the formulation and process development phase of drug development.

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          Reviewing the Basics of Stats

          Reviewing the Basics of Stats

            A quick check of the fundamentals will help you approach manufacturing analytics with the right statistical mindset.

            Pharmaceutical manufacturers today rely on process-related statistics for sound decision making related to Quality by Design (QbD), process improvement initiatives and investigations. They pull data from disparate sources across manufacturing networks to populate graphs, charts and predictive models designed to alert teams to potential problems and prevent unwanted batch outcomes.

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            Pharmaceutical Manufacturing eBook: Holistic QbD

            Pharmaceutical Manufacturing eBook: Holistic QbD

              Sponsored by: West Pharmaceuticals

              Since FDA introduced the term to the pharmaceutical industry in 2005, the concept of pharmaceutical quality by design (pharma QbD), a framework for building quality into pharmaceuticals during drug development has been slowly gaining ground. Discrete industries are no strangers to QbD. Now, however, some vendors to the pharmaceutical industries are applying pharma QbD principles to develop their pharmaceutical industry products. This e-book offers general resources in the area of QbD, and discusses how West Pharmaceuticals has been bringing a QbD approach to its packaging components. Read Now.

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