5th edition FACT-JACIE Cellular Therapy Accreditation Manual, Version 5.3 [Free Download]

Description:

This Accreditation Manual is intended to accompany the FACT-JACIE International Standards for Cellular Therapy Product Collection, Processing, and Administration, Fifth Edition, 2012 (the Standards). The purpose of the manual is to provide guidance to applicants for accreditation and to on-site inspectors. Requirements to become accredited are detailed in the FACT-JACIE Standards. This manual is intended to explain the intent and rationale for specific standards, and to provide explanations, examples, and alternative approaches that will be helpful in the accreditation process. This is not an exhaustive list of possible ways to meet the Standards, and the only intent is to provide examples since there are many effective mechanisms by which to achieve compliance with FACT-JACIE Standards and by which to inspect applicant cellular therapy programs.