About the FACT Standards. The Standards are the cornerstone of the FACT accreditation program. Believing that quality care can only be achieved if both clinical and laboratory issues are effectively addressed, the FACT Standards are the only set of requirements that emphasize the clinical use of cellular therapy products collected and processed with rigorous controls. FACT-JACIE International Standards Accreditation Manual Seventh Edition- DRAFT 6 These Standards are designed to provide voluntary minimum guidelines for programs, facilities, and individuals performing cell transplantation and therapy . · 28/02/ - This is the final date for sending completed applications based on the 6th edition of the FACT-JACIE Standards. All applications after this date must be made under the 7th edition. 01/03/ - The 7th edition of the FACT-JACIE Cellular Therapy Standards, Accreditation Manual, Checklist and associated documents will be published.
FACT-JACIE International Standards Accreditation Manual DRAFT Fifth Edition 9 Current Good Tissue Practice: The methods used in, and the facilities and controls used for, the manufacture of cellular therapy products to prevent the introduction or transmission of communicable diseases, including all steps in collection, donor screening and testing. This Accreditation Manual is intended to accompany the -JACIE International Standards for FACT Hematopoietic Cellular Therapy Product Collection, Processing, and Administration, Seventh Edition, (the Standards). The purpose is to explain the intent and rationale of specific standards, to provide. 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 seventh edition of the FACT-JACIE Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration has been published. These guidelines have until recently been formulated in 3 documents: 1) FACT Common Standards for Cellular Therapies, 2) FACT-JACIE Hematopoietic Cell Therapy. The 4th edition of the joint FACT-JACIE standards covers all aspects of clinical transplant programs, collection facilities (bone marrow [BM] and peripheral.
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