ISPE
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 English is als..
$285.00 $570.00
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 revision o..
$230.00 $460.00
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 Edition) provi..
$230.00 $460.00
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 both the re..
$230.00 $460.00
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 Computerized S..
$230.00 $460.00
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 of GxP S..
$230.00 $460.00
GAMP Good Practice Guide: Data Integrity - Manufacturing Records
Manufacturing systems, with their link to the physical process, have an obvious impact on patient sa..
$187.50 $375.00
GAMP Good Practice Guide: Data Integrity by Design
This Guide is intended to encourage organizations to adopt a risk-based approach to ensuring data in..
$187.50 $375.00
GAMP Good Practice Guide: Electronic Data Archiving
This Guide provides a rational and scaleable approach to electronic data archiving through the devel..
$230.00 $460.00
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 manufac..
$230.00 $460.00
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, Active Phar..
$257.50 $515.00
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 Dosage (OSD) ..
$257.50 $515.00
ISPE Baseline Guide: Volume 3 - Sterile Product Manufacturing Facilities, Third Edition
The ISPE Baseline® Guide: Sterile Product Manufacturing Facilities (Third Edition) covers engineerin..
$257.50 $515.00
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 design, con..
$347.50 $695.00
ISPE Baseline Guide: Volume 5 - Commissioning and Qualification, 2nd Edition
The ISPE Baseline® Guide: Commissioning and Qualification (Second Edition) provides practical guidan..
$397.50 $795.00
ISPE Baseline Guide: Volume 6 - Biopharmaceutical Manufacturing Facilities
This second edition of the ISPE Baseline® guide: Biopharmaceutical Manufacturing Facilities intends ..
$257.50 $515.00