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Guidance Documents

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  • Good Practice Guide: Membrane-Based WFI Systems

    Good Practice Guide: Membrane-Based WFI Systems

    Published
    The ISPE Good Practice Guide: Membrane-Based Water for Injection Systems provides expert guidance on the design, operation, maintenance, and quality aspects of membrane-based WFI systems, including generation, storage, and distribution. This Guide reflects an industry wide collaborative effort by a diverse range of industry experts that include equipment providers, engineering firms, consultants, and pharmaceutical manufacturers. The information presented in this guide is the combination of proven technological solutions, microbial control methods, process analytical technology, and operations and maintenance practices.
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  • Good Practice Guide: Continuous Manufacturing of Oral Solid Dosage Forms

    Good Practice Guide: Continuous Manufacturing of Oral Solid Dosage Forms

    Published
    This Guide reviews the unit operations typically employed in continuous manufacturing and aims to establish a set of minimum equipment requirements for each system to function as part of an integrated process train. While most of the units are well-understood and used in batch manufacturing, the Guide considers the changes in physical and automation requirements that will allow each unit to work in concert as part of a successful continuous manufacturing platform. Operations unique to CM, loss-in-weight feeding and continuous blending, are discussed, including how these systems affect upstream and downstream operations.
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  • APQ Guide: Change Management (CM) System

    APQ Guide: Change Management (CM) System

    Published
    The change management system is a fundamental element of the PQS described in ICH Q10. Effective change management enables quality improvement and ensures a continued state of control. The ISPE APQ Guide: Change Management System provides a quality management framework for assessing and advancing change management systems.
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  • Good Practice Guide: Controlled Temperature Chambers 2nd Edition

    Good Practice Guide: Controlled Temperature Chambers 2nd Edition

    Published
    The Guide has been revised to align with current industry practice, particularly with respect to the ISPE Baseline® Guide: Commissioning and Qualification (Second Edition), presenting a cost-effective way of demonstrating and maintaining compliance. The most significant changes are:
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Viral Vector Platforms: Intersection of Facility and Program

Pharmaceutical Engineering Magazine
Realizing the promise of any novel viral vector therapeutic depends on the innovator’s ability to constantly meet evolving program requirements set in the product’s preclinical; clinical; chemistry, manufacturing, and controls (CMC); and market strategies. A...
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May / June 2022

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