Regulatory aspects of cellular therapy product in Europe: JACIE accreditation in a processing facility.
In 1997, the Joint Accreditation Committee ISCT & EBMT (JACIE) was created. The following year, it approved the first edition of standards for haemopoietic progenitor cell collection, processing and transplantation. The purpose of the standards is to ensure a minimal level of quality, alertness and homogeneity in the implementation of autologous and allogeneic haemopoietic stem cell transplantation (HSCT) programme in onco-hematology. The acquisition of accreditation is based upon the system of examination by trained medical professionals according to countries endorsements with the national regulation obligations applicable to HSCT. In 2008, the fourth edition has been launched. The range of application of the standards comprises both donors and recipients, and all phases of collection, processing, storage and administration of haemopoietic progenitor cells. Among the accredited processing facilities, a few have been integrated JACIE standards into their existing management quality system which is inspected by national health authority. In France, the comparison between JACIE standards and the good manufacturing practices of cellular therapy product reveals some common points and some differences to apply.
Caunday
Olivia
O
Unité de thérapie cellulaire et Tissulaire, CHU Nancy Brabois and Faculté de Médecine de Nancy, Vandoeuvre les Nancy, France. o.caunday@chu-nancy.fr
Bensoussan
Danièle
D
Decot
Véronique
V
Bordigoni
Pierre
P
Stoltz
Jean François
JF
D000068:Accreditation / Q000331:legislation & jurisprudence*; D018070:Biological Specimen Banks / Q000331:legislation & jurisprudence*; D064987:Cell- and Tissue-Based Therapy / Q000592:standards*; D005602:France; D033161:Government Regulation; D018380:Hematopoietic Stem Cell Transplantation / Q000331:legislation & jurisprudence*; D007221:Industry / Q000331:legislation & jurisprudence*; D023822:Tissue Engineering / Q000331:legislation & jurisprudence*