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Guidance Documents

  • APQ Guide: Process Performance & Product Quality Monitoring System (PPPQMS)

    APQ Guide: Process Performance & Product Quality Monitoring System (PPPQMS)

    Published
    The Process Performance and Product Quality Monitoring System (PPPQMS) is a fundamental element of the PQS described in ICH Q10. An effective PPPQMS ensures a state of control is maintained and facilitates continual improvement. The ISPE APQ Guide: PPPQMS provides a quality management framework for assessing and advancing an organization’s PPPQMS.
  • GAMP 5 Guide 2nd Edition

    GAMP 5 Guide 2nd Edition

    Published
    Maintaining the principles and framework of the First Edition, GAMP® 5 (Second Edition) is newly revised and expanded to address the increased importance of service providers, evolving approaches to software development, and the more widespread use of software tools and automation. It highlights the use of Critical Thinking by knowledgeable and experienced SMEs to define appropriate approaches.
  • 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.
  • 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.
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guideline on Registration of Pharmaceuticals for Human Use (M4)International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. “The...