ISPE

ISPE
ISPE provides education, training, forums, and technical documents for professionals in pharmaceutical manufacturing. The Society publishes best-practice guides on a wide array of topics, including bulk pharmaceutical chemicals, sterile manufacturing facilities, commissioning and qualification, biopharmaceutical manufacturing facilities, and technology transfer.

GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems (German Version)

GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems (German Version)

Please note: This is the German version of GAMP 5. A version of this publication in Englis..

$285.00 $570.00

GAMP Good Practice Guide:  A Risk-Based Approach to GxP Process Control

GAMP Good Practice Guide: A Risk-Based Approach to GxP Process Control

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

$230.00 $460.00

GAMP Good Practice Guide: A Risk-Based Approach to Calibration Management, Second Edition

GAMP Good Practice Guide: A Risk-Based Approach to Calibration Management, Second Edition

The GAMP Good Practice Guide: A Risk-Based Approach to Calibration Management (Second Editio..

$230.00 $460.00

GAMP Good Practice Guide: A Risk-Based Approach to Compliant Electronic Records and Signatures

GAMP Good Practice Guide: A Risk-Based Approach to Compliant Electronic Records and Signatures

The appropriate management of electronic records and signatures is of current concern to bot..

$230.00 $460.00

GAMP Good Practice Guide: A Risk-Based Approach to GxP Compliant Laboratory Computerized Systems (Second Edition)

GAMP Good Practice Guide: A Risk-Based Approach to GxP Compliant Laboratory Computerized Systems (Second Edition)

The ISPE GAMP® Good Practice Guide: A Risk-Based Approach to GxP Compliant Laboratory Comput..

$230.00 $460.00

GAMP Good Practice Guide: A Risk-Based Approach to Testing of GxP Systems (Second Edition)

GAMP Good Practice Guide: A Risk-Based Approach to Testing of GxP Systems (Second Edition)

This Guide helps the reader to maximize testing efficiency without compromising the quality ..

$230.00 $460.00

GAMP Good Practice Guide: Data Integrity - Manufacturing Records

GAMP Good Practice Guide: Data Integrity - Manufacturing Records

Manufacturing systems, with their link to the physical process, have an obvious impact on pa..

$187.50 $375.00

GAMP Good Practice Guide: Data Integrity by Design

GAMP Good Practice Guide: Data Integrity by Design

This Guide is intended to encourage organizations to adopt a risk-based approach to ensuring..

$187.50 $375.00

GAMP Good Practice Guide: Electronic Data Archiving

GAMP Good Practice Guide: Electronic Data Archiving

This Guide provides a rational and scaleable approach to electronic data archiving through t..

$230.00 $460.00

GAMP Good Practice Guide: Manufacturing Execution Systems - A Strategic and Program Management Approach

GAMP Good Practice Guide: Manufacturing Execution Systems - A Strategic and Program Management Approach

The Guide uses a complete lifecycle approach to the development and use of MES for regulated..

$230.00 $460.00

ISPE Baseline Guide: Volume 1 - Active Pharmaceutical Ingredients (Second Edition)

ISPE Baseline Guide: Volume 1 - Active Pharmaceutical Ingredients (Second Edition)

This revised Guide builds on the original principles of ISPE's Baseline® Guide Volume 1, Act..

$257.50 $515.00

ISPE Baseline Guide: Volume 2 - Oral Solid Dosage Forms

ISPE Baseline Guide: Volume 2 - Oral Solid Dosage Forms

This is the third edition of the ISPE Baseline® Guide for New and Renovated Oral Solid Dosag..

$257.50 $515.00

ISPE Baseline Guide: Volume 3 - Sterile Product Manufacturing Facilities, Third Edition

ISPE Baseline Guide: Volume 3 - Sterile Product Manufacturing Facilities, Third Edition

The ISPE Baseline® Guide: Sterile Product Manufacturing Facilities (Third Edition) covers en..

$257.50 $515.00

ISPE Baseline Guide: Volume 4 - Water and Steam Systems, Third Edition

ISPE Baseline Guide: Volume 4 - Water and Steam Systems, Third Edition

The ISPE Baseline Guide® Water and Steam Systems (Third Edition) aims to assist with the des..

$347.50 $695.00

ISPE Baseline Guide: Volume 5 - Commissioning and Qualification, 2nd Edition

ISPE Baseline Guide: Volume 5 - Commissioning and Qualification, 2nd Edition

The ISPE Baseline® Guide: Commissioning and Qualification (Second Edition) provides practica..

$397.50 $795.00

ISPE Baseline Guide: Volume 6 - Biopharmaceutical Manufacturing Facilities

ISPE Baseline Guide: Volume 6 - Biopharmaceutical Manufacturing Facilities

This second edition of the ISPE Baseline® guide: Biopharmaceutical Manufacturing Facilities ..

$257.50 $515.00

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