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Guidance Document License Agreement

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.

Reproduction of multiple copies of these materials, in whole or in part, for the purposes of commercial distribution is prohibited.

Membership discounts are available only to current members and are intended for individual use of the guides, not for resale.

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ISPE GPG: Tech Transfer (3rd Ed) Bound

Transfer of manufacturing processes and analytical procedures between facilities or laboratories is a necessary part of pharmaceutical development ...

Member Price: $ 215.00 / € 195.00
Non-Member Price: $ 515.00 / € 468.00

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ISPE GPG: Tech Transfer (3rd Ed) Download

Transfer of manufacturing processes and analytical procedures between facilities or laboratories is a necessary part of pharmaceutical development ...

Member Price: $ 215.00 / € 195.00
Non-Member Price: $ 515.00 / € 468.00

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ISPE GPG: Single-Use Technology (Bound)

Single-use technology has grown in both complexity of design and criticality of application in the past twenty years, offering increased flexibilit...

Member Price: $ 215.00 / € 195.00
Non-Member Price: $ 515.00 / € 468.00

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ISPE GPG: Single-Use Technology Download

Single-use technology has grown in both complexity of design and criticality of application in the past twenty years, offering increased flexibilit...

Member Price: $ 215.00 / € 195.00
Non-Member Price: $ 515.00 / € 468.00

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ISPE GPG: Sampling Water, Steam, Gases Download

The ISPE Good Practice Guide on Sampling for Pharmaceutical Water, Steam, and Process Gases was created for users of water, steam, compressed air o...

Member Price: $ 215.00 / € 195.00
Non-Member Price: $ 515.00 / € 468.00

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ISPE GPG: IMP Reverse Logistics Download

Most current reverse logistics processes lack effective planning, thorough application of risk management, and well-defined roles and responsibilit...

Member Price: $ 295.00 / € 268.00
Non-Member Price: $ 595.00 / € 541.00

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ISPE GPG: Quality Laboratory Facilities (Bound)
ISPE has produced the industry's first Guidance Document to establish a baseline for the design of Quality Laboratory Facilities. The ISPE Good Practi...
Member Price: $ 215.00 / € 195.00
Non-Member Price: $ 515.00 / € 468.00

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ISPE GPG: Quality Laboratory Facilities Download
ISPE has produced the industry's first Guidance Document to establish a baseline for the design of Quality Laboratory Facilities. The ISPE Good Practi...
Member Price: $ 215.00 / € 195.00
Non-Member Price: $ 515.00 / € 468.00

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ISPE GPG: Process Validation (Bound)

Covering a wide variety of manufacturing types, the ISPE Good Practice Guide: Practical Implementation of the Lifecycle Approach to Process Validat...

Member Price: $ 215.00 / € 195.00
Non-Member Price: $ 515.00 / € 468.00

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ISPE GPG: Process Validation Download

Covering a wide variety of manufacturing types, the ISPE Good Practice Guide: Practical Implementation of the Lifecycle Approach to Process Validat...

Member Price: $ 215.00 / € 195.00
Non-Member Price: $ 515.00 / € 468.00

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ISPE GPG: Project Management (Bound)

This Guide provides good practice approaches which promote the successful integration of GxP with relevant project management activities to ensure ...

Member Price: $ 215.00 / € 195.00
Non-Member Price: $ 515.00 / € 468.00

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ISPE GPG: Project Management Download

This Guide provides good practice approaches which promote the successful integration of GxP with relevant project management activities to ensure ...

Member Price: $ 215.00 / € 195.00
Non-Member Price: $ 515.00 / € 468.00

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ISPE GPG: Process Gases Download

The ISPE Good Practice Guide: Process Gases aims to define current good practices within pharmaceutical manufacturing applications, providing infor...

Member Price: $ 215.00 / € 195.00
Non-Member Price: $ 515.00 / € 468.00

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ISPE GPG: PACLAW (Bound)
The ISPE Good Practice Guide: Packaging, Labeling, and Warehousing Facilities is the industry's only guidance relating to the design, construction and...
Member Price: $ 215.00 / € 195.00
Non-Member Price: $ 515.00 / € 468.00

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ISPE GPG: PACLAW Download
The ISPE Good Practice Guide: Packaging, Labeling, and Warehousing Facilities is the industry's only guidance relating to the design, construction and...
Member Price: $ 215.00 / € 195.00
Non-Member Price: $ 515.00 / € 468.00

add to your shopping cart

ISPE GPG: Ozone Sanitization (Bound)
The ISPE Good Practice Guide: Ozone Sanitization of Pharmaceutical Water Systems provides important insight into the design and use of pharmaceutical ...
Member Price: $ 215.00 / € 195.00
Non-Member Price: $ 515.00 / € 468.00

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ISPE GPG: Ozone Sanitization Download
...
Member Price: $ 215.00 / € 195.00
Non-Member Price: $ 515.00 / € 468.00

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ISPE GPG: Operations Management (Bound)

For the purposes of this Guide, operations are defined as the transformative process within a series of activities, along a value chain extending f...

Member Price: $ 215.00 / € 195.00
Non-Member Price: $ 515.00 / € 468.00

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ISPE GPG: Operations Management Download

For the purposes of this Guide, operations are defined as the transformative process within a series of activities, along a value chain extending f...

Member Price: $ 215.00 / € 195.00
Non-Member Price: $ 515.00 / € 468.00

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ISPE GPG: NIMPs Download
The ISPE Good Practice Guide: Harmonizing the Definition and Use of Non-Investigational Medicinal Products (NIMPs) aims to provide practical operation...
Member Price: $ 95.00 / € 86.00
Non-Member Price: $ 395.00 / € 359.00

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ISPE GPG: Mgmt of Engineering Standards Download

The ISPE Good Practice Guide on the Management of Engineering Standards aims to provide a common understanding and approach to the management of En...

Member Price: $ 95.00 / € 86.00
Non-Member Price: $ 395.00 / € 359.00

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ISPE GPG: Membrane-Based WFI Systems (Bound)

The ISPE Good Practice Guide: Membrane-Based Water for Injection Systems provides expert guidance on the design, operation, maintenance, and qualit...

Member Price: $ 295.00 /
Non-Member Price: $ 595.00 /

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ISPE GPG: Membrane-Based WFI Systems (Download)

The ISPE Good Practice Guide: Membrane-Based Water for Injection Systems provides expert guidance on the design, operation, maintenance, and qualit...

Member Price: $ 295.00 /
Non-Member Price: $ 595.00 /

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ISPE GPG: Maintenance (2nd Ed) Download

This Guide is focused on maintenance in GMP areas and provides a practical and consistent interpretation of the necessary elements of a pharmaceuti...

Member Price: $ 295.00 / € 268.00
Non-Member Price: $ 595.00 / € 541.00

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ISPE GPG: Knowledge Management (Bound)

ICH Q10 outlines three objectives: achieve product realization, establish and maintain a state of control, and facilitate continual improvement. Em...

Member Price: $ 295.00 / € 268.00
Non-Member Price: $ 595.00 / € 541.00

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