Guidance Documents

Information about ISPE's Guidance Documents, white papers, Knowledge Briefs and other written technical guidance.

SPE GAMP Good Practice Guide: IT Infrastructure Control and Compliance (Second Edition)
News & Press Releases

Just Released! ISPE GAMP Good Practice Guide: IT Infrastructure Control and Compliance (Second Edition)

01 September 2017
Announcing the release of our latest guidance document, ISPE GAMP ® Good Practice Guide: IT Infrastructure Control and Compliance (Second Edition) . This guide provides guidance on meeting regulatory expectations for compliant IT (Information...
Guidance Documents
News & Press Releases

ISPE Releases Baseline Guide: Risk-Based Manufacture of Pharmaceutical Products (Second Edition)

20 July 2017
ISPE announced the release of their latest guidance document, ISPE Baseline® Guide: Risk-Based Manufacture of Pharmaceutical Products (Second Edition) . This guide provides a scientific, risk-based approach (based on ICH Q9 Quality Risk Management)...
Baseline Guide: Oral Solid Dosage
News & Press Releases

New Baseline Guide: Oral Solid Dosage is Now Available

09 December 2016
ISPE has announced the third edition of the ISPE Baseline® Guide: Oral Solid Dosage (OSD) Forms . This newly revised guide is available in book and PDF format. “The key takeaway for the OSD Baseline® Guide is to give owners, engineers, and equipment...