United Kingdon Affiliate
UK Affiliate

Guidance Documents

  • 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.
  • GAMP RDI Good Practice Guide: Data Integrity by Design

    GAMP RDI Good Practice Guide: Data Integrity by Design

    Published
    This ISPE GAMP® RDI Good Practice Guide: Data Integrity by Design supports organizations as they embrace and implement a holistic approach by leveraging data governance and knowledge management activities to drive continual improvement in data integrity.
The ISPE Pharma 4.0™ Special Interest Group (SIG) launched in 2015 to provide a road map for new challenges of digitalization, Industry 4.0, and the smart factory. The Special Interest Group addresses how pharmaceutical industry...