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.
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Please note: This is the German version of GAMP 5. A version of this publication in Englis..
This GAMP® Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems is a re..
The GAMP Good Practice Guide: A Risk-Based Approach to Calibration Management (Second Editio..
The appropriate management of electronic records and signatures is of current concern to bot..
The ISPE GAMP® Good Practice Guide: A Risk-Based Approach to GxP Compliant Laboratory Comput..
This Guide helps the reader to maximize testing efficiency without compromising the quality ..
Manufacturing systems, with their link to the physical process, have an obvious impact on pa..
This Guide is intended to encourage organizations to adopt a risk-based approach to ensuring..
This Guide provides a rational and scaleable approach to electronic data archiving through t..
The Guide uses a complete lifecycle approach to the development and use of MES for regulated..
This revised Guide builds on the original principles of ISPE's Baseline® Guide Volume 1, Act..
This is the third edition of the ISPE Baseline® Guide for New and Renovated Oral Solid Dosag..
The ISPE Baseline® Guide: Sterile Product Manufacturing Facilities (Third Edition) covers en..
The ISPE Baseline Guide® Water and Steam Systems (Third Edition) aims to assist with the des..
The ISPE Baseline® Guide: Commissioning and Qualification (Second Edition) provides practica..
This second edition of the ISPE Baseline® guide: Biopharmaceutical Manufacturing Facilities ..
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