Ispe Headquarters

year of publication	ISBN	author(s)	title
1992	978-1-931879-00-2	ISPE	Bulk Pharmaceutical Chemicals (Ispe Baseline Pharmaceutical Engineering Guide, Volume 1)
1998	978-1-931879-01-9	''	ISPE Baseline Guide: Oral Solid Dosage Forms
1999	978-1-931879-02-6	''	Sterile Manufacturing Facilities (Ispe Baseline Pharmaceutical Engineering Guide, Volume 3)
2001	978-1-931879-03-3	''	ISPE Baseline Guide: Volume 4: Water and Steam Systems
2005	978-1-931879-06-4	''	ISPE Baseline Guide: Commissioning and Qualification: 5
2004	978-1-931879-09-5	ISPE	Pharmaceutical Engineering Guides for New and Renovated Facilities: Biopharmaceutical Manufacturing Facilities
2003	978-1-931879-13-2	''	ISPE Good Practice Guide: Technology Transfer
2001	978-1-931879-17-0		The GAMP Guide for Validation of Automated Systems
2005	978-1-931879-25-5	ISPE	GAMP Good Practice Guide: Calibration Management
2003	978-1-931879-27-9	''	GAMP Good Practice Guide: Validation of Process Control Systems
2002	978-1-931879-32-3	''	Introductory U.s. Clinical Trials Materials Training Guide
2003	978-1-931879-33-0	''	Investigational Materials Sample Retention Guide (ISPE Investigational Products Resources)
2005	978-1-931879-35-4	ISPE	ISPE Good Practice Guide: Assessing the Particulate Containment Performance of Pharmaceutical Equipment
''	978-1-931879-38-5		A Risk-Based Approach to Compliant Electric Records and Signatures (ISPE GAMP® Good Practice Guide)
''	978-1-931879-39-2	ISPE	GAMP 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
2006	978-1-931879-48-4	''	Comprehensive Guide to Clinical Materials: A Handbook for Training Clinical Materials Professionals
	978-1-931879-49-1		Commissioning and Qualification of Pharmaceutical Water and Steam Systems (ISPE Good Practice Guide)
2007	978-1-931879-52-1	Per Olsson	Electronic Data Archiving (ISPE GAMP Good Practice Guide)
2008	978-1-931879-54-5	ISPE	ISPE Good Practice Guide: Good Engineering Practice
2007	978-1-931879-55-2	Official Publisher ISPE	Active Pharmaceutical Ingredients: June 2007 (Baseline Pharmaceutical Engineering Guides)
2009	978-1-931879-56-9	ISPE	Maintenance (ISPE Good Practice Guide)
2009	978-1-931879-57-6	ISPE	Heating, Ventilation, and Air Conditioning (HVAC) (ISPE Good Practice Guide)
2007	978-1-931879-58-3	''	Ispe Good Practice Guide: Development of Investigational Therapeutic Biological Products
2008	978-1-931879-61-3	Ispe Headquarters	GAMP 5: A Risk-based Approach to Compliant Gxp Computerized Systems
2016	978-1-931879-67-5	ISPE	Oral Solid Dosage Forms (Baseline Guide, Volume 2)
2010	978-1-931879-68-2	ISPE	A 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)
''	978-1-931879-96-5		Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP) (ISPE Baseline® Guide)
''	978-1-931879-99-6	ISPE	A Risk-Based Approach to Calibration Management (GAMP® Good Practice Guide)