Italy Affiliate
Italy Affiliate

Guidance Documents

  • 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.
  • Good Practice Guide: IMP Reverse Logistics

    Good Practice Guide: IMP Reverse Logistics

    Published
    Every year the number of clinical trials conducted across the globe rises in a concerted effort to develop new or improved medicinal products that ultimately improve lives. The pharmaceutical industry has developed standards and best practices in almost every aspect of a trial. There is, however, one area that lacks foundational best practices: that of medicinal product accountability, reconciliation, and return for destruction, otherwise known as reverse logistics.
  • APQ Guide: Management Responsibilities & Review (MRR)

    APQ Guide: Management Responsibilities & Review (MRR)

    Published
    ICH Q10 sets a clear expectation regarding the role of strong leadership in terms of demonstrating and communicating “strong and visible support for the pharmaceutical quality system.” The ISPE APQ Guide: Management Responsibilities and Management Review provides a quality management framework for assessing and advancing leadership systems. It provides a systematic and proactive approach to evaluating management responsibilities highlighted in ICH Q10 as well as other key leadership components:
Industry 4.0 applications in biopharma involve the complete spectrum of data science throughout the entire product life cycle of many disparate entity types. Tools such as digitalization, modern data science, and the industrial internet of...