• ISPE Membership
• About ISPE
• 

GAMP^® 5

GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems provides pragmatic and practical industry guidance that aims to achieve compliant computerized systems that are fit for intended use in an efficient and effective manner, while also enabling innovation and technological advance.

• GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems

GAMP^® Good Practice Guides

Reflecting current regulatory expectations and good practices, the the GAMP series of Good Practice Guides help to narrow interpretation of regulatory standards for improved compliance and quality, efficiency, and cost reductions.

• A Risk-Based Approach to Calibration Management (Second Edition)
• A Risk-Based Approach to Electronic Records and Signatures
• A Risk-Based Approach to GxP Compliant Laboratory Computerized Systems (Second Edition)
• A Risk-Based Approach to GxP Process Control Systems (Second Edition)
• A Risk-Based Approach to Operation of GxP Computerized Systems - A Companion Volume to GAMP 5
• A Risk-Based Approach to Testing of GxP Systems (Second Edition)
• Electronic Data Archiving
• Global Information Systems Control and Compliance
• IT Infrastructure Control and Compliance
• Legacy Systems
• Manufacturing Execution Systems – A Strategic and Program Management Approach
• GAMP Good Practice Guides Under Development

ISPE Baseline^® Pharmaceutical Engineering Guides for New and Renovated Facilities

Created in partnership with the US Food and Drug Administration (FDA), ISPE's Baseline Guides offer practical answers to the complex, dynamic challenges facing facility designers today by addressing GMP and non-GMP regulations.

• Volume 1: Active Pharmaceutical Ingredients (Second Edition) - Revision to Bulk Pharmaceutical Chemicals
• Volume 2: Oral Solid Dosage Forms (Second Edition)
• Volume 3: Sterile Product Manufacturing Facilities (Second Edition)
• Volume 4: Water and Steam Systems (Second Edition)
• Volume 5: Commissioning and Qualification
• Volume 6: Biopharmaceutical Manufacturing Facilities
• Volume 7: Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP)
• Baseline Guides Under Development

ISPE Guides

ISPE’s Guides offer practical advice on regulatory initiatives by providing effective, cost-efficient approaches and encouraging innovation and technological advances while achieving regulatory compliance.

• ISPE Guide: Science and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment
• ISPE Guides Under Development

ISPE Good Practice Guides

ISPE Good Practice Guides (GPGs) provide information or advice on a particular topic area and explain underlying technical principles and suggest solutions in an area where no single answer is correct and where several outcomes may be possible.

• ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification
• ISPE Good Practice Guide: Assessing the Particulate Containment Performance of Pharmaceutical Equipment (Second Edition)
• ISPE Good Practice Guide: Booklet Labels
• ISPE Good Practice Guide: Cold Chain Management
• ISPE Good Practice Guide: Commissioning and Qualification of Pharmaceutical Water and Steam Systems
• ISPE Good Practice Guide: Comparator Management
• ISPE Good Practice Guide: Development of Investigational Therapeutic Biological Products
• ISPE Good Practice Guide: Good Engineering Practice
• ISPE Good Practice Guide: Harmonizing the Definition and Use of Non-Investigational Medicinal Products (NIMPs)
• ISPE Good Practice Guide: Heating, Ventilation, and Air Conditioning (HVAC)
• ISPE Good Practice Guide: Interactive Response Technology
• ISPE Good Practice Guide: Maintenance
• ISPE Good Practice Guide: Ozone Sanitization of Pharmaceutical Water Systems
• ISPE Good Practice Guide: Packaging, Labeling, and Warehousing Facilities
• ISPE Good Practice Guide: Process Gases
• ISPE Good Practice Guide: Project Management for the Pharmaceutical Industry
• ISPE Good Practice Guide: Quality Laboratory Facilities
• ISPE Good Practice Guides Under Development

PQLI^® Guides

Product Quality Lifecycle Implementation^® (PQLI^®) Good Practice Guides (GPGs) provide information on global solutions to implementation challenges of ICH guidances.

• PQLI Overview Good Practice Guide
• Product Quality Lifecycle Implementation (PQLI) from Concept to Continual Improvement
  Part 1: Product Realization using QbD, Concepts and Principles
• Product Quality Lifecycle Implementation (PQLI) from Concept to Continual Improvement
  Part 2: Product Realization using QbD, Illustrative Example
• Product Quality Lifecycle Implementation (PQLI) from Concept to Continual Improvement
  Part 3: Change Management System as a Key Element of a Pharmaceutical Quality System
• ISPE PQLI Guides Under Development

• ISPE Publications Catalog - Prices through 31 December 2013

My ISPE

• Privacy Policy
• Contact Us
• Terms of Use