ISPE Indonesia Affiliate Members
Indonesia Affiliate

Guidance Documents

  • APQ Guide: Cultural Excellence

    APQ Guide: Cultural Excellence

    Published
    Cultural excellence is the expressed and implied ways in which an organization operates. Excellence in quality culture is essential for delivering robust and sustained quality performance and ensuring patient-focused outcomes. Culture determines quality outcomes by affecting the organization’s ability to identify and act upon near-miss shortages, ensuring the integrity of its data, assuring transparent problem escalation, and striving for operational excellence.
  • 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.
Many organizations are evaluating how advanced therapy medicinal products (ATMPs) and other traditional modalities may be combined within the same facility or within a newly constructed agnostic building. This article outlines a broad framework to...