ISPE San Fran Chapter Members

Guidance Documents

  • Good Practice Guide: Knowledge Management in the Pharmaceutical Industry

    Good Practice Guide: Knowledge Management in the Pharmaceutical Industry

    Published
    ICH Q10 outlines three objectives: achieve product realization, establish and maintain a state of control, and facilitate continual improvement. Embracing these objectives can be best achieved using the dual enablers, Knowledge Management (KM) and Quality Risk Management (QRM).
  • Good Practice Guide: Maintenance 2nd Edition

    Good Practice Guide: Maintenance 2nd Edition

    Published
    Maintenance can impact both the quality of products and the compliance of pharmaceutical processes. Maintenance programs have long been recognized as critical to the success of the operations they support.
  • Good Practice Guide: Equipment Reliability

    Good Practice Guide: Equipment Reliability

    Published
    Equipment reliability is concerned with the risk of failures in equipment and processes, providing focus on equipment availability, fitness for purpose, and cost. The strategy and tactics of reliability contribute to realizing the value of equipment throughout its useful life and mission.
  • APQ Guide: Corrective Action & Preventive Action (CAPA) System

    APQ Guide: Corrective Action & Preventive Action (CAPA) System

    Published
    The ISPE APQ Guide: Corrective Action and Preventive Action (CAPA) System provides a quality management framework for assessing and advancing CAPA system maturity level by evaluating several key components.
This article focuses on pragmatic quality- and risk-based approaches to IT infrastructure. It covers recommendations made by a US FDA/industry team linked to the US FDA Center for Devices and Radiological Health (CDRH) Case for...