Created in partnership with the US Food and Drug Administration (FDA), ISPE's Baseline® Guides offer practical answers to the complex, dynamic challenges facing facility designers today by addressing GMP and non-GMP regulations.
ISPE Baseline® Guide Volume 7: Risk-Based Manufacture of
Pharmaceutical Products (Risk-MaPP)
Published: 8 September 2010
ISPE Good Practice Guides (GPGs) provide information or advice on a particular topic area and explain underlying technical principles and suggest solutions in an area where no single answer is correct and where several outcomes may be possible.
Product Quality Lifecycle Implementation (PQLI) Good Practice Guides (GPGs) provide information on global solutions to implementation challenges of ICH guidance.