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Accredited Organization, Guest, Inspector, Inspector Trainee, NonMember -
This Accreditation Manual, Edition 8.2, is intended to accompany the FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration, Eighth Edition, 2021 (the Standards). The purpose is to explain the intent and rationale for specific standards, to provide examples of alternative approaches that would be considered compliant with standards, and to detail the type of documentation that may be used to verify compliance during the accreditation process. This information is intended to be helpful to applicants for accreditation and to on-site inspectors. There are potentially many effective ways to meet the Standards. The examples listed are not requirements and are not all-inclusive.