Browse Categories

Not a Member?

Gain industry knowledge, learn best practices, network with peers, and advance your career with the largest not-for-profit association in the pharmaceutical industry.

Join now and get Member Pricing on your purchase!

Learn More
* ISPE does not pay customs or duties on international shipping.
Shipping and Return Policy
Publication Order Form

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.

View the Guidance Document License Agreement   

 

 

Keyword Search

Title:
Description:
Item Number:
Categories:
Advanced Seach
 

12
Page 1 of 2
ISPE GPG: Good Engineering Practice (2nd Ed) Bound

The ISPE Good Practice Guide: Good Engineering Practice (Second Edition) defines the practices and processes under GEP that support and enable the ...

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

add to your shopping cart

GAMP Guide: Records & Data Integrity (Bound)

The importance of data integrity is reflected in guidance, citations, and public comments of Regulators and Health Agencies. A number of companies ...

Member Price: $ 395.00
Non-Member Price: $ 695.00

add to your shopping cart

GAMP Guide: Records & Data Integrity (Download) German

The importance of data integrity is reflected in guidance, citations, and public comments of Regulators and Health Agencies. A number of companies ...

Member Price: $ 395.00
Non-Member Price: $ 695.00

add to your shopping cart

GAMP Guide: Records & Data Integrity Download

The importance of data integrity is reflected in guidance, citations, and public comments of Regulators and Health Agencies. A number of companies ...

Member Price: $ 395.00
Non-Member Price: $ 695.00

add to your shopping cart

GAMP GPG: Testing of GxP Sys (2nd Ed) - German DL
This Guide helps the reader to maximize testing efficiency without compromising the quality of GxP Systems by focusing testing on areas that have the ...
Member Price: $ 215.00
Non-Member Price: $ 515.00

add to your shopping cart

GAMP GPG: Testing of GxP Sys (2nd Ed) Download
This Guide helps the reader to maximize testing efficiency without compromising the quality of GxP Systems by focusing testing on areas that have the ...
Member Price: $ 215.00
Non-Member Price: $ 515.00

add to your shopping cart

GAMP GPG: GxP Process Control Sys (2nd Ed) Bound

This GAMP® Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems is a revision of the GAMP® Good Practice Guide: Validation of ...

Member Price: $ 215.00
Non-Member Price: $ 515.00

add to your shopping cart

GAMP GPG: GxP Process Control Sys (2nd Ed) Download
This GAMP® Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems is a revision of the GAMP® Good Practice Guide: Validation of Pro...
Member Price: $ 215.00
Non-Member Price: $ 515.00

add to your shopping cart

GAMP GPG: Operation GxP Computerized Sys (Bound)

During the operational life of a GxP system regulators usually focus on the integrity, consistency, and completeness of controls required to mainta...

Member Price: $ 215.00
Non-Member Price: $ 515.00

add to your shopping cart

GAMP GPG: Operation GxP Computerized Sys - German DL
During the operational life of a GxP system regulators usually focus on the integrity, consistency, and completeness of controls required to maintain ...
Member Price: $ 215.00
Non-Member Price: $ 515.00

add to your shopping cart

GAMP GPG: Operation GxP Computerized Sys (Download)
During the operational life of a GxP system regulators usually focus on the integrity, consistency, and completeness of controls required to maintain ...
Member Price: $ 215.00
Non-Member Price: $ 515.00

add to your shopping cart

GAMP GPG: Mobile Applications Download

This new GAMP Good Practice Guide is intended to provide a risk-based approach to implementing and supporting regulated mobile apps, and will be of...

Member Price: $ 215.00
Non-Member Price: $ 515.00

add to your shopping cart

GAMP GPG: Mfg Execution Systems (Bound)

The Guide uses a complete lifecycle approach to the development and use of MES for regulated manufacturing as a collection or domain of manufacturi...

Member Price: $ 215.00
Non-Member Price: $ 515.00

add to your shopping cart

GAMP GPG: Mfg Execution Systems Download
The Guide uses a complete lifecycle approach to the development and use of MES for regulated manufacturing as a collection or domain of manufacturing ...
Member Price: $ 215.00
Non-Member Price: $ 515.00

add to your shopping cart

GAMP GPG: Mfg Execution Systems (Chinese DL)
The Guide uses a complete lifecycle approach to the development and use of MES for regulated manufacturing as a collection or domain of manufacturing ...
Member Price: $ 215.00
Non-Member Price: $ 515.00

add to your shopping cart

GAMP GPG: GxP Compliant Lab Sys (2nd Ed) Download
Recently updated to conform with GAMP® 5 concepts and terminology, as well as recent regulatory and industry developments, the ISPE GAMP® Good Practic...
Member Price: $ 215.00
Non-Member Price: $ 515.00

add to your shopping cart

GAMP GPG: IT Infrastructure (2nd Ed) Download

The ISPE GAMP Good Practice Guide: IT Infrastructure Control and Compliance (Second Edition) applies a structured approach, including risk managem...

Member Price: $ 215.00
Non-Member Price: $ 515.00

add to your shopping cart

GAMP GPG: Global Info Systems (2nd Ed) Bound

This revised GAMP® Good Practice Guide provides comprehensive and up-to-date guidance on the risk-based development, implementation, validation, an...

Member Price: $ 215.00
Non-Member Price: $ 515.00

add to your shopping cart

GAMP GPG: Global Info Systems (2nd Ed) Download

This revised GAMP® Good Practice Guide provides comprehensive and up-to-date guidance on the risk-based development, implementation, validation, an...

Member Price: $ 215.00
Non-Member Price: $ 515.00

add to your shopping cart

GAMP GPG: Enabling Innovation Download

The ISPE GAMP® Good Practice Guide: Enabling Innovation - Critical Thinking, Agile, IT Service Management provides information to support the adopt...

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

add to your shopping cart

GAMP GPG: GCP Systems & Data [eClinical] Download

The ISPE GAMP Good Practice Guide: Validation and Compliance of Computerized GCP Systems and Data (Good eClinical Practice) is intended to provide ...

Member Price: $ 215.00
Non-Member Price: $ 515.00

add to your shopping cart

GAMP RDI GPG: DI - Manufacturing Records (Bound)

The ISPE GAMP® RDI Good Practice Guide: Data Integrity - Manufacturing Records provides practical and pragmatic advice on areas such as regulated r...

Member Price: $ 250.00
Non-Member Price: $ 550.00

add to your shopping cart

GAMP RDI GPG: DI - Manufacturing Records Download

The ISPE GAMP® RDI Good Practice Guide: Data Integrity - Manufacturing Records provides practical and pragmatic advice on areas such as regulated r...

Member Price: $ 250.00
Non-Member Price: $ 550.00

add to your shopping cart

GAMP RDI GPG: DI - Key Concepts (Bound)

The ISPE GAMP® RDI Good Practice Guide: Data Integrity - Key Concepts provides detailed practical guidance to support data integrity within a regul...

Member Price: $ 250.00
Non-Member Price: $ 550.00

add to your shopping cart

GAMP RDI GPG: DI - Key Concepts Download

The ISPE GAMP® RDI Good Practice Guide: Data Integrity - Key Concepts provides detailed practical guidance to support data integrity within a regul...

Member Price: $ 250.00
Non-Member Price: $ 550.00

add to your shopping cart

Page 1 of 2
12