ISPE Midwest Chapter Members
Midwest Chapter

Guidance Documents

  • Good Practice Guide: Asset Management

    Good Practice Guide: Asset Management

    Published
    The ISPE Good Practice Guide: Asset Management provides practical guidance for establishing an asset management system that enables organizations to realize increased value from their assets, both physical and non-physical. This Guide identifies best practices in strategic asset management as outlined in the ISO 55000 series of standards. An effective asset management system translates the organization’s objectives into asset-related decisions, plans, and activities using a risk-based approach. This Guide provides recommendations, examples, and resources to help organizations in the development or improvement of their asset management system.
  • Baseline Guide Vol 4: Water & Steam Systems 3rd Edition

    Baseline Guide Vol 4: Water & Steam Systems 3rd Edition

    Published
    The ISPE Baseline Guide® Water and Steam Systems (Third Edition) aims to assist with the design, construction, operation, and lifecycle management of new and existing water and steam systems. It is intended to help meet Good Manufacturing Practices (GMPs) and comply with regulations and related guidance.
  • Baseline Guide Vol 5: Commissioning & Qualification 2nd Edition

    Baseline Guide Vol 5: Commissioning & Qualification 2nd Edition

    Published
    The ISPE Baseline® Guide: Commissioning and Qualification (Second Edition) provides practical guidance on the implementation of a science and risk-based approach for the Commissioning and Qualification (C&Q) of pharmaceutical manufacturing facilities, systems, utilities, and equipment to demonstrate that they are suitable for the intended purpose.
  • GAMP RDI Good Practice Guide: Data Integrity - Manufacturing Records

    GAMP RDI Good Practice Guide: Data Integrity - Manufacturing Records

    Published
    The ISPE GAMP® RDI Good Practice Guide: Data Integrity – Manufacturing Records provides practical and pragmatic advice on areas such as regulated records, data flows, and risk management approaches, with particular focus on process control systems, manufacturing execution systems, and the interfaces and relationship between them.
Cell and gene therapies are the latest revolution in medicine manufacturing. Unlike small molecules or traditional biotech products, these therapies introduce cells and genes into a patient to treat the underlying cause of a disease—they...