ISPE Guidance Documents by Title A - Z

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Title

Series

A Risk-Based Approach to Calibration Management (Second Edition)

GAMP® Good Practice Guides

A Risk-Based Approach to GxP Compliant Laboratory Computerized Systems (Second Edition)

GAMP® Good Practice Guides

A Risk-Based Approach to GxP Process Control Systems (Second Edition)

GAMP® Good Practice Guides

A Risk-Based Approach to Operation of GxP Computerized Systems

GAMP® Good Practice Guides

A Risk-Based Approach to Testing of GxP Systems (Second Edition)

GAMP® Good Practice Guides

Active Pharmaceutical Ingredients (Second Edition) - Revision to Bulk Pharmaceutical Chemicals 

Baseline® Guides

Applied Risk Management for Commissioning and Qualification

ISPE Good Practice Guides

Assessing the Particulate Containment Performance of Pharmaceutical Equipment (Second Edition)

ISPE Good Practice Guides

Biopharmaceutical Manufacturing Facilities (Second Edition) New

Baseline® Guides

Biopharmaceutical Process Development and ManufacturingNew

ISPE Guides

 

Booklet Labels

ISPE Good Practice Guides

Clinical Supply Systems New

ISPE Good Practice Guides

Cold Chain Management

ISPE Good Practice Guides

Commissioning and Qualification

Baseline® Guides

Commissioning and Qualification of Pharmaceutical Water and Steam Systems

ISPE Good Practice Guides

Comparator Management

ISPE Good Practice Guides

Development of Investigational Therapeutic Biological Products

ISPE Good Practice Guides

Electronic Data Archiving

GAMP® Good Practice Guides

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

GAMP®

Global Information Systems

GAMP® Good Practice Guides

Good Engineering Practice

ISPE Good Practice Guides

Harmonizing the Definition and Use of Non-Investigational Medicinal Products (NIMPs)

ISPE Good Practice Guides

HVAC

ISPE Good Practice Guides

Interactive Response Technology 

ISPE Good Practice Guides

IT Infrastructure Control and Compliance

GAMP® Good Practice Guides

Legacy Systems

GAMP® Good Practice Guides

Maintenance

ISPE Good Practice Guides

Manufacturing Execution Systems – A Strategic and Program Management Approach

GAMP® Good Practice Guides

Oral Solid Dosage Forms (Second Edition)

Baseline® Guides

Ozone Sanitization of Pharmaceutical Water Systems

ISPE Good Practice Guides

Packaging, Labeling, and Warehousing Facilities

ISPE Good Practice Guides

Process Gases

ISPE Good Practice Guides

Product Quality Lifecycle Implementation® (PQLI®) Guide: Overview of Product Design, Development and Realization: A Science- and Risk-Based Approach to Implementation

PQLI Guides

Product Quality Lifecycle Implementation® (PQLI®) from Concept to Continual Improvement
Part 1: Product Realization using QbD, Concepts and Principles
 

PQLI Guides

Product Quality Lifecycle Implementation® (PQLI®) from Concept to Continual Improvement
Part 2: Product Realization using QbD, Illustrative Example
 

PQLI Guides

Product Quality Lifecycle Implementation® (PQLI®) from Concept to Continual Improvement
Part 3: Change Management System as a Key Element of a Pharmaceutical Quality System

PQLI Guides

Product Quality Lifecycle Implementation® (PQLI®) from Concept to Continual Improvement
Part 4: Process Performance and Product Quality Monitoring System (PP&PQMS)

PQLI Guides

Project Management for the Pharmaceutical Industry

ISPE Good Practice Guides

Quality Laboratory Facilities 

ISPE Good Practice Guides

Risk-Based Approach to Electronic Records and Signatures

GAMP® Good Practice Guides

Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP)

Baseline® Guides

Science and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment

ISPE Guides

Sterile Product Manufacturing Facilities (Second Edition

Baseline® Guides

Technology Transfer (Second Edition) New

ISPE Good Practice Guides

Water and Steam Systems (Second Edition) 

Baseline® Guides
Last Update: 03 April 2014

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