Fact-jacie accreditation manual






















This Accreditation Manual is intended to accompany the FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration, Eighth Edition, (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 Product ID: FACT initiated a virtual inspection process in January to enable accredited cellular therapy facilities to complete their renewal accreditation. We expect this process to be in place as long as necessary to minimize the coronavirus pandemic risks to our cellular therapy community, volunteers, and patients. The objective of the FACT-JACIE Standards is to promote quality medical and laboratory practice in hematopoietic progenitor cell transplantation and therapies using hematopoietic derived cellular products. The scope of the Standards includes hematopoietic progenitor cells (HPCs), nucleated cells or mononuclear cells from any hematopoietic tissue source collected .


The objective of the FACT-JACIE Standards is to promote quality medical and laboratory practice in hematopoietic progenitor cell transplantation and therapies using hematopoietic derived cellular products. The scope of the Standards includes hematopoietic progenitor cells (HPCs), nucleated cells or mononuclear cells from any hematopoietic tissue source collected for therapeutic use other than as HPCs, immune effector cells (IECs), and genetically modified cells. This Accreditation Manual is intended to accompany the FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration, Eighth Edition, (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 the sixth collaboration to publish comprehensive quality-based Standards in cellular therapy between the Foundation for the Accreditation of Cellular Therapy (FACT) and JACIE, the Joint Accreditation Committee of ISCT and EBMT of the European Society for Blood and Marrow Transplantation (EBMT). FACT was founded in by the American Society for Transplantation and Cellular Therapy (ASTCT) and the International Society for Cell and Gene Therapy (ISCT), published the first edition of.


FACT-JACIE Standards. The FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection. The objective of the FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration is to promote. FACT-JACIE Hematopoietic Cellular Therapy Accreditation Standards (6th edition).

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