ISPE Nordic Affiliate Members
Nordic Affiliate

Guidance Documents

  • Good Practice Guide: Technology Transfer 3rd Edition

    Good Practice Guide: Technology Transfer 3rd Edition

    Transfer of manufacturing processes and analytical procedures between facilities or laboratories is a necessary part of pharmaceutical development and commercialization. Technology transfers take the outputs of process or method development activities and transfer the knowledge to a different location where a process or analytical procedure will be operated.
  • Good Practice Guide: Single-Use Technology

    Good Practice Guide: Single-Use Technology

    Single-use technology has grown in both complexity of design and criticality of application in the past twenty years, offering increased flexibility while significantly reducing the risk of contamination in manufacturing equipment. The implementation of single-use technology into a process requires a well-defined plan that minimizes surprises during the later stages of implementation.
  • GAMP RDI Good Practice Guide: Data Integrity - Key Concepts

    GAMP RDI Good Practice Guide: Data Integrity - Key Concepts


    Published: October 2018
    Pages: 196

  • Japan Affiliate: Pest Control Manual

    Japan Affiliate: Pest Control Manual

    The ISPE Japan Affiliate Manual on Pest Control expands on the concepts and policies set forth in the previous ISPE Japan Affiliate Handbook on Pest Control (English Translation, version 4) and offers advice for new and aging GMP facilities. It proposes plans for incorporating pest control best practices into the project schedule for new construction, including advice on integrating pest control requirements during all phases of construction, training construction staff, and determining areas to inspect both during and at the end of construction.

ISPE Blog

Pharmaceutical Engineering magazine’s March–April 2016 Special Report 1 highlighted the increasing importance of data integrity for companies throughout the global GMP-regulated industry. This is especially true during health authority inspections. 2 , 3 , 4...