ISPE Singapore Committee Members 2018
Singapore Affiliate

Guidance Documents

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

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

    Published
    Thisguide provides a hands-on approach to support the life science industry in the development and establishment of compliant cleaning programs that meet or exceed regulatory expectations.
  • 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.
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...