Guidance Document Translations

The following titles are available as digital only unless otherwise specified.


Chinese


French


German


Japanese

Please visit the ISPE Japan Affiliate website or contact ispe-admi@ispe.gr.jp for more details or to order these guides.

Baseline® Guides

  • Active Pharmaceutical Ingredients (Second Edition)
  • Biopharmaceutical Manufacturing Facilities (Second Edition)
  • Commissioning and Qualification (Second Edition)
  • Oral Solid Dosage Forms (Third Edition)
  • Sterile Product Manufacturing Facilities (Second Edition)
  • Risk-Based Manufacture of Pharmaceutical Products [Risk-MaPP] (Second Edition)

ISPE Good Practice Guides

  • Assessing the Particulate Containment Performance of Pharmaceutical Equipment (Second Edition)
  • Commissioning and Qualification of Pharmaceutical Water and Steam Systems (Second Edition)
  • Good Engineering Practice [GEP] (First Edition)
  • Heating, Ventilation, and Air Conditioning [HVAC] (First Edition) 
  • Maintenance (First Edition)
  • Operations Management (First Edition) 
  • Packaging, Labeling, and Warehousing Facilities (First Edition) 
  • Project Management (First Edition) 
  • Technology Transfer (Second Edition) 

GAMP® / GAMP® Good Practice Guides

  • GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Fifth Edition)
  • GAMP® Guide: Records and Data Integrity (First Edition)
  • A Risk-Based Approach to GxP Compliant Laboratory Computerized Systems (Second Edition)
  • A Risk-Based Approach to GxP Process Control Systems (GPCS) (Second Edition)
  • A Risk-Based Approach to Operation of GxP Computerized Systems (OGCS) (First Edition)
  • A Risk-Based Approach to Testing of GxP Systems (Second Edition) 
  • IT Infrastructure Control and Compliance (First Edition)
  • Manufacturing Execution Systems - A Strategic and Program Management Approach (MES) (First Edition)

Investigational Products Publications

  • Comprehensive Guide to Clinical Materials - A Handbook for Training CM Professionals (First Edition)

ISPE PQLI® Guide Series

  • Part 1 - Product Realization using Quality by Design (QbD): Concepts and Principles, including Overview, Criticality, Design Space, and Control Strategy (First Edition)
  • Part 2 - Product Realization using Quality by Design (QbD): Illustrative Example (First Edition)

Poland


Russian


Spanish

Please visit the ISPE Argentina Affiliate website or contact info@ispe.org.ar for more details or to order this guide.
  • ISPE Good Practice Guide: Heating, Ventilation, and Air Conditioning (HVAC)