Guidance Document Translations Available

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The following titles are available as bound copies unless otherwise specified.

Chinese

Please contact China@ispe.org for more details or to order these guides.

  • Baseline® Guide: Oral Solid Dosage Forms (Second Edition)
  • Baseline® Guide: Sterile Product Manufacturing Facilities (Second Edition)
  • GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Fifth Edition)

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 (First Edition)
  • Commissioning and Qualification (First Edition)
  • Oral Solid Dosage Forms (Second Edition)
  • Sterile Product Manufacturing Facilities (Second Edition)
  • Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP) (First Edition)

ISPE Good Practice Guides

  • Assessing the Particulate Containment Performance of Pharmaceutical Equipment (Second Edition)
  • Commissioning and Qualification of Pharmaceutical Water and Steam Systems (First Edition)
  • Good Engineering Practice (GEP) (First Edition)
  • Maintenance (First Edition)

GAMP® / GAMP® Good Practice Guides

  • GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Fifth Edition)
  • A Risk-Based Approach to Compliant Electronic Records and Signatures (ER&S) (First 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)
  • IT Infrastructure Control and Compliance (First Edition)
  • Manufacturing Execution Systems - A Strategic and Program Management Approach (MES) (First Edition) - available as electronic only
  • Validation of Laboratory Computerized Systems (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)

Spanish

Please visit the ISPE Argentia 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)
Last Update: 28 March 2014

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