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Guidance Documents

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  • APQ Guide: Management Responsibilities & Review (MRR)

    APQ Guide: Management Responsibilities & Review (MRR)

    Published
    ICH Q10 sets a clear expectation regarding the role of strong leadership in terms of demonstrating and communicating “strong and visible support for the pharmaceutical quality system.” The ISPE APQ Guide: Management Responsibilities and Management Review provides a quality management framework for assessing and advancing leadership systems. It provides a systematic and proactive approach to evaluating management responsibilities highlighted in ICH Q10 as well as other key leadership components:
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  • Good Practice Guide: Knowledge Management in the Pharmaceutical Industry

    Good Practice Guide: Knowledge Management in the Pharmaceutical Industry

    Published
    ICH Q10 outlines three objectives: achieve product realization, establish and maintain a state of control, and facilitate continual improvement. Embracing these objectives can be best achieved using the dual enablers, Knowledge Management (KM) and Quality Risk Management (QRM).
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  • Good Practice Guide: Maintenance 2nd Edition

    Good Practice Guide: Maintenance 2nd Edition

    Published
    Maintenance can impact both the quality of products and the compliance of pharmaceutical processes. Maintenance programs have long been recognized as critical to the success of the operations they support.
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  • Good Practice Guide: Equipment Reliability

    Good Practice Guide: Equipment Reliability

    Published
    Equipment reliability is concerned with the risk of failures in equipment and processes, providing focus on equipment availability, fitness for purpose, and cost. The strategy and tactics of reliability contribute to realizing the value of equipment throughout its useful life and mission.
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Opportunities in Continuous Manufacturing of Large Molecules

Pharmaceutical Engineering Magazine
Continuous manufacturing has attracted significant interest over the past decade for small molecules formulated as drug products. The case for adopting continuous manufacturing platforms for manufacturing biologics (i.e., large proteins or biologic products such as...
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