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The contents of ISPE’s guidance documents, both printed and digital, are protected by law and intended solely for the personal non-commercial use of the individual purchaser.
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Transfer of manufacturing processes and analytical procedures between facilities or laboratories is a necessary part of pharmaceutical development ...
Single-use technology has grown in both complexity of design and criticality of application in the past twenty years, offering increased flexibilit...
The ISPE Good Practice Guide on Sampling for Pharmaceutical Water, Steam, and Process Gases was created for users of water, steam, compressed air o...
Most current reverse logistics processes lack effective planning, thorough application of risk management, and well-defined roles and responsibilit...
Covering a wide variety of manufacturing types, the ISPE Good Practice Guide: Practical Implementation of the Lifecycle Approach to Process Validat...
The ISPE Good Practice Guide: Project Management for the Pharmaceutical Industry provides good practice approaches which promote the successful int...
The ISPE Good Practice Guide: Process Gases aims to define current good practices within pharmaceutical manufacturing applications, providing infor...
For the purposes of this Guide, operations are defined as the transformative process within a series of activities, along a value chain extending f...
The ISPE Good Practice Guide on the Management of Engineering Standards aims to provide a common understanding and approach to the management of En...
This Guide is focused on maintenance in GMP areas and provides a practical and consistent interpretation of the necessary elements of a pharmaceuti...
ICH Q10 outlines three objectives: achieve product realization, establish and maintain a state of control, and facilitate continual improvement. Em...
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