Ispe Headquarters

year of pub­li­ca­ti­onISBNauthor(s)title
1992978-1-931879-00-2ISPEBulk Pharmaceutical Chemicals (Ispe Baseline Pharmaceutical Engineering Guide, Volume 1)
1998978-1-931879-01-9   ''ISPE Baseline Guide: Oral Solid Dosage Forms
1999978-1-931879-02-6   ''Sterile Manufacturing Facilities (Ispe Baseline Pharmaceutical Engineering Guide, Volume 3)
2001978-1-931879-03-3   ''ISPE Baseline Guide: Volume 4: Water and Steam Systems
2005978-1-931879-06-4   ''ISPE Baseline Guide: Commissioning and Qualification
2004978-1-931879-09-5ISPEPharmaceutical Engineering Guides for New and Renovated Facilities: Biopharmaceutical Manufacturing Facilities
2003978-1-931879-13-2   ''ISPE Good Practice Guide: Technology Transfer
2001978-1-931879-17-0The GAMP Guide for Validation of Automated Systems
2005978-1-931879-25-5ISPEGAMP Good Practice Guide: Calibration Management
2003978-1-931879-27-9   ''GAMP Good Practice Guide: Validation of Process Control Systems
2002978-1-931879-32-3   ''Introductory US Clinical Trials Materials Training Guide
2003978-1-931879-33-0   ''Investigational Materials Sample Retention Guide (ISPE Investigational Products Resources)
2005978-1-931879-35-4ISPEISPE Good Practice Guide: Assessing the Particulate Containment Performance of Pharmaceutical Equipment
  ''978-1-931879-38-5A Risk-Based Approach to Compliant Electric Records and Signatures (ISPE GAMP® Good Practice Guide)
  ''978-1-931879-39-2ISPEGAMP Good Practice Guide: Validation of Laboratory Computerized Systems
  ''978-1-931879-42-2   ''GAMP Good Practice Guide: IT Infrastructure Control and Compliance
  ''978-1-931879-43-9   ''GAMP Good Practice Guide: Global Information Systems Control and Compliance
2006978-1-931879-48-4   ''Comprehensive Guide to Clinical Materials: A Handbook for Training Clinical Materials Professionals
978-1-931879-49-1Commissioning and Qualification of Pharmaceutical Water and Steam Systems (ISPE Good Practice Guide)
2007978-1-931879-52-1Per OlssonElectronic Data Archiving (ISPE GAMP Good Practice Guide)
2008978-1-931879-54-5ISPEISPE Good Practice Guide: Good Engineering Practice
2007978-1-931879-55-2Official Publisher ISPEActive Pharmaceutical Ingredients: June 2007 (Baseline Pharmaceutical Engineering Guides)
2009978-1-931879-56-9ISPEMaintenance (ISPE Good Practice Guide)
2009978-1-931879-57-6ISPEHeating, Ventilation, and Air Conditioning (HVAC) (ISPE Good Practice Guide)
2007978-1-931879-58-3   ''Ispe Good Practice Guide: Development of Investigational Therapeutic Biological Products
2008978-1-931879-61-3Ispe HeadquartersGAMP 5: A Risk-based Approach to Compliant Gxp Computerized Systems
2016978-1-931879-67-5ISPEOral Solid Dosage Forms (Baseline Guide, Volume 2)
2010978-1-931879-68-2ISPEA Risk-Based Approach to Operation of GxP Computerized Systems, A Companion Volume to GAMP 5 (GAMP G
  ''978-1-931879-75-0   ''Manufacturing Execution Systems - A Strategic and Program Management Approach (GAMP Good Practice Guide)
  ''978-1-931879-96-5Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP) (ISPE Baseline® Guide)
  ''978-1-931879-99-6ISPEA Risk-Based Approach to Calibration Management (GAMP® Good Practice Guide)