ISPE LA Chapter Members
LA Chapter

Guidance Documents

  • 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:
  • Guide: ATMPs - Autologous Cell Therapy

    Guide: ATMPs - Autologous Cell Therapy

    Published
    Advanced Therapy Medicinal Product (ATMP) therapies include cells, engineered tissues, or the manipulation of the patient’s genome. This is in contrast with traditional manufacturing processes for compounds that are synthetically derived (i.e., small molecule) or proteins or peptides expressed by cellular systems (i.e., large molecule biopharmaceuticals). ATMPs are based on genes, cells, or tissues delivered to patients to provide a therapeutic benefit based on a specific target of interest.
  • Good Practice Guide: Good Engineering Practice 2nd Edition

    Good Practice Guide: Good Engineering Practice 2nd Edition

    Published
    The ISPE Good Practice Guide: Good Engineering Practice (Second Edition) defines the practices and processes under GEP that support and enable the design, delivery, and operation of engineered systems. The scope of GEP covers the complete lifecycle of engineering projects and engineered systems from conceptual design to retirement. This Guide considers the entire range of pharmaceutical engineering activity and identifies key attributes of GEP within it, including how GEP relates to and interfaces with GxP.
  • GAMP Good Practice Guide: Enabling Innovation

    GAMP Good Practice Guide: Enabling Innovation

    Published
    The drive within life sciences to improve patient safety and product quality, and provide value to society, while reducing costs requires constant and effective innovation. However, because the pharmaceutical industry operates in a highly regulated sector, some practitioners may apply unthinking, prescriptive, and rigid approaches that are not commensurate to the needs of the process, the nature of the system, and the real risk to the product and the patient.
Emerging Leaders has grown from an initiative for interactions among early-career professionals entering ISPE into much more: a training ground, a networking organization, and a new foundation for the future of ISPE and the industry...