ISPE Pacific Northwest Chapter Members
Pacific Northwest Chapter

Guidance Documents

  • Guide: Cleaning Validation Lifecycle - Applications, Methods, & Controls

    Guide: Cleaning Validation Lifecycle - Applications, Methods, & Controls

    Published

    Published: August 2020
    Pages: 236

  • Good Practice Guide: Critical Utilities GMP Compliance

    Good Practice Guide: Critical Utilities GMP Compliance

    Published
    The goal of the ISPE Good Practice Guide: Critical Utilities GMP Compliance – How to Be Compliant and Ready to Prove It is to help pharmaceutical organizations achieve and maintain their critical utility systems in a state of control, and then be able to efficiently demonstrate their systems’ Good Manufacturing Practice (GMP) compliance to regulatory inspectors and auditors.
  • Good Practice Guide: HVAC & Process Equipment Air Filters

    Good Practice Guide: HVAC & Process Equipment Air Filters

    Published
    The ISPE Good Practice Guide: HVAC and Process Equipment Air Filters aims to be a valuable reference on the selection, application, specification, testing, and operation and maintenance of filters in the pharmaceutical industry. This Guide is intended to be used as supplement to the ISPE Good Practice Guide: Heating, Ventilation, and Air Conditioning (HVAC), providing detailed information into the subject of air filters in HVAC and process equipment applications.
  • 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.
In the pharmaceutical industry, digitalization involves developing and implementing digital technologies at all levels of pharmaceutical operations. The aim is to transform the industry by capturing, analyzing, and using vast amounts of data collected from...