The following titles are available as digital only unless otherwise specified.
Chinese
- GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (First Edition)
- GAMP® Good Practice Guide: Manufacturing Execution Systems
- ISPE Good Practice Guide: Process Validation
French
German
- GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (First Edition)
- GAMP® Good Practice Guide: A Risk-Based Approach to Operation of GxP Computerized Systems (OGCS)
- GAMP® Good Practice Guide: A Risk-Based Approach to Testing of GxP Systems (Second Edition)
- GAMP® Guide: Records and Data Integrity
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 (Third 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 (Second Edition)
- GAMP® Guide: Records and Data Integrity (First Edition)
- GAMP RDI Good Practice Guide: Data Integrity - Key Concepts (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)