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ISPE GPG: Good Engineering Practice (2nd Ed) Bound - USD
ISPE GPG: Good Engineering Practice (2nd Ed) Bound - USD
Good Practice Guide: Good Engineering Practice 2nd Edition
Discounted member price: 295.00
You could save 50.4%

The ISPE Good Practice Guide: Good Engineering Practice (Second Edition) defines the practices and processes under GEP that support and enable the design, delivery, and operation of engineered systems. The scope of GEP covers the complete lifecycle of engineering projects and engineered systems from conceptual design to retirement. This Guide considers the entire range of pharmaceutical engineering activity and identifies key attributes of GEP within it, including how GEP relates to and interfaces with GxP. Updates for the second edition include alignment with current industry practice, particularly with respect to the ISPE BaselineĀ® Guide: Commissioning and Qualification (Second Edition) which incorporates ASTM E2500, EU GMP Annex 15, ICH Q8, Q9, and Q10, and applicable regulatory guidance. This Good Practice Guide incorporates the concepts and application of Quality Risk Management (QRM), specifically the application of GEP as an enabler for QRM-based integrated Commissioning and Qualification (C&Q).

Member Price: $ 295.00
Non Member Price: $ 595.00

ISBN: 978-1-946964-47-2
Author: ISPE
Publisher: ISPE
Format: Bound
Pages: 252
Publishing Date: 10/21