Information about ISPE's Guidance Documents, white papers, Knowledge Briefs and other written technical guidance.
The ATMPs - Autologous Cell Therapy Guide focuses primarily on manufacturing facility development and design for autologous cell therapies for parenteral use. This Guide provides an overview of the critical aspects of ATMP facility design as well as the key relationship between current process/facility attribute alignment and how that changes in the ATMP space.
ISPE published the 2nd Edition of the ISPE Good Practice Guide: Controlled Temperature Chambers – Commissioning and Qualification, Mapping and Monitoring in...
Knowledge Management (KM) is a discipline (akin to Quality Risk Management (QRM) or Lean Six Sigma) that focuses on how organizations create, manage, use, and share knowledge. The publication of ICH Q10 in 2008 saw the formal designation of KM as a key enabler for an effective Pharmaceutical Quality System (PQS), along with QRM. Since then, the industry has acknowledged the...
Late last month, ISPE published the 2nd Edition of the ISPE Good Practice Guide: Good Engineering Practice. This revision comes a decade and a half after the original guide was...
