Guidance Documents

  • 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.
  • 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.
  • 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.
ISPE Engage

ISPE Engage

Where Global Pharmaceutical Professionals Connect

The ISPE member networking forum Community Connection is being relaunched with some exciting updates! Now called ISPE Engage, we've updated the platform to include:

  • An open forum for all Members as a place for everyone to virtually connect and Shape the Future of Pharma™
  • Name and logo redesign
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...