JACIE Processing Standards

Transcription

1 JACIE Processing Standards Christian CHABANNON Faculté de Médecine. Aix-Marseille Université Centre de Thérapie Cellulaire. Département de Biologie du Cancer. Institut Paoli-Calmettes. Comprehensive Cancer Center Inserm CBT-1409 Marseille, France 2015 EBMT Annual Meeting. Istanbul. Turkey Tuesday, March 24th, 2015 HEMATOPOIETIC CELLULAR THERAPY Accreditation Manual SIXTH EDITION JACIE EBMT2015. Istanbul. March 24,

2 Disclosures None relevant to the present presentation 2

3 6 TH EDITION INTERNATIONAL STANDARDS FOR HEMATOPOIETIC CELLULAR THERAPY PRODUCT COLLECTION, PROCESSING, AND ADMINISTRATION 5 TH EDITION INTERNATIONAL STANDARDS FOR CELLULAR THERAPY PRODUCT COLLECTION, PROCESSING, AND ADMINISTRATION

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5 Part Total 5th ed. Total 6th ed. % change Part B % Part CM % Part C % Part D % Total % 5

6 New standards Changes from 5th No change Reworded Section title Unmerged Part B 19% 13% 44% 18% 3% 2%2% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Part CM 8% 13% 47% 20% 11% Merged 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Part C 11% 16% 39% 23% 8% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Part D 8% 15% 48% 18% 7% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

7 Main Issues 1. HLA typing laboratory accreditation 2. Stability studies 3. Deviation management 4. Minimum number of marrow collection procedures 5. Continuing education 6. Accreditation for chimerism testing 7. ISBT 128 implementation 8. Central venous catheter placement 9. Qualification of facilities prior to distribution 10. Clinical outcome requirements 7

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9 New Standards in section D Environmental control D2.1.2 Oxygen sensors shall be appropriately placed and utilized in areas where liquid nitrogen is present. D2.2 Processing Facility parameters and environmental conditions shall be controlled to protect the safety and comfort of personnel. D2.4.1 The Processing Facility shall qualify environmental control systems and validate cleaning and sanitation procedures appropriate for the environmental classification and degree of manipulation performed. 9

10 New Standards in section D Qualification plans / Validation D Qualification plans shall be reviewed and approved by the Processing Facility Director or designee. D Each validation shall include: D An approved validation plan, including conditions to be validated. D Acceptance criteria. D Data collection. D Evaluation of data. D Summary of results. 10

11 New Standards in section D Cord Blood Units / Processing vs Manufacturing D8.4.3 Cord blood units that have not been red cell reduced prior to cryopreservation shall be washed prior to administration. D8.4.4 Cord blood units that have been red cell reduced prior to cryopreservation should be diluted or washed prior to administration. D The Processing Facility shall adhere to good manufacturing practices (GMP) appropriate for the degree of cellular therapy product manipulation. D8.13 There shall be a procedure to confirm the identity of cord blood units if confirmatory typing cannot be performed on attached segments. D Cryopreserved samples shall be retained according to institutional Standard Operating Procedures. 11

12 New Standards in section D Cord Blood Units / Processing vs Manufacturing D If the original identifier is replaced, documentation shall link the new identifier to the original. D7.4.7 Cellular therapy products distributed for nonclinical purposes shall be labeled with the statement, For Nonclinical Use Only. 12

13 New Standards in section D Shipping & Transportation D The outer container shall be secured. D If the primary container or temperature of the cellular therapy product has been compromised, the Processing Facility Director or designee shall give specific authorization to return the product to inventory. D The receiving facility shall review and verify product specifications provided by the manufacturer, if applicable. D For cellular therapy products received from an external facility, there shall be documented evidence of donor eligibility screening and testing in accordance with applicable laws and regulations. 13

14 New Standards in section D Quality controls on cryopreserved cellular therapy products D9.2.2 There shall be a written stability program that evaluates the viability and potency of cryopreserved cellular therapy products, minimally annually. 14

15 New Standards in section D Processing Facility Director There shall be a Processing Facility Director with a medical degree or doctoral degree in a relevant science, qualified by a minimum of two (2) years training and experience for the scope of activities carried out in the Processing Facility. 15

16 Labelling issues ISBT128 or not? 16

17 -FACT-JACIE requirements for labeling Successive editions of the FACT-JACIE standards have consistently called upon ISBT 128 implementation in JACIE accredited programs since the 4th edition, based on the following principles: FACT-JACIE Standards are to be used and implemented worldwide A global system for labelling is an essential component to promote harmonization and cross-border exchanges of hematopoietic grafts 17

18 FACT-JACIE requirements for labeling Wording has evolved from the 4 th to the 6 th edition of FACT-JACIE standards: 4 th edition C7.2.4 & D7.2.4 Cellular therapy products shall be identified according to the proper name of the product, including appropriate modifiers, manipulations, and attributes, as defined by ISBT 128. See Appendix IV. 5 th edition C7.1.1 & D7.1.1 Cellular therapy products shall be identified according to the proper name of the product, including appropriate modifiers and attributes, as defined in ISBT 128 Standard Terminology for Blood, Cellular Therapy, and Tissue Product Descriptions. D7.1.2 If the Processing Facility has not fully implemented ISBT 128 technology, an implementation plan for the usage of ISBT 128 coding and labeling shall be in place. 18

19 FACT-JACIE requirements for labeling Wording has evolved from the 4 th to the 6 th edition of FACT-JACIE standards: 5 th edition C7.1.1 & D7.1.1 Cellular therapy products shall be identified according to the proper name of the product, including appropriate modifiers and attributes, as defined in ISBT 128 Standard Terminology for Blood, Cellular Therapy, and Tissue Product Descriptions. D7.1.2 If the Processing Facility has not fully implemented ISBT 128 technology, an implementation plan for the usage of ISBT 128 coding and labeling shall be in place. 6 th edition C7.1.1 & D7.1.1 Cellular therapy products shall be identified according to the proper name of the product, including appropriate attributes, as defined in ISBT 128 Standard Terminology for Blood, Cellular Therapy, and Tissue Product Descriptions C7.1.2 & D7.1.2 If coding and labeling technologies have not yet been implemented, the Processing Facility shall be actively implementing ISBT

20 FACT-JACIE requirements for labeling In the fifth edition, cellular therapy programs are required to create a plan for fully implementing ISBT 128 technology. At an early stage in the implementation plan for introducing bar coding or other machine readable technology, the Clinical Program, Collection Facility, and/or Processing Facility as appropriate, should register with ICCBBA, Inc., the organization charged with the international maintenance of this database, in order to obtain the necessary documents and databases. In the recently published sixth edition, Both FACT and JACIE recognize the significant benefits of international standardization of coding and labelling in cellular therapy, and support the international efforts to implement ISBT 128, the international information standard for transfusion and transplantation. These FACT-JACIE Standards require the use of this terminology for cellular therapy products as applicable. This sixth edition of FACT-JACIE Standards requires that accredited programs be actively implementing ISBT 128. It is understood that implementation requires a transition period and organizations that are inspected soon after publication may not be completely finished. 20

21 Actively implementing ISBT 128 At a minimum, FACT defines actively implementing to include the following elements: 1. Registration with ICCBBA; 2. Identification or creation of appropriate product codes; 3. Label designs according to the requirements of ICCBBA for Cellular Therapy Products; 4. Label validation; 5. Use of scanned information at the time products are released from collection, received into the laboratory, and at distribution from the processing facility. 21

22 The JACIE vs Eurocode case EU Directive 2002/98/EC requests a unique identification of blood and blood components in the Community Therefore implemented by many facilities in Europe, and in some cases uniformly adopted by all facilities in a country European Directive 2004/23/EC requires the EC to design a single European coding (SEC) system FACT-JACIE requests the implementation of the ISBT 128 coding system Political, Financial & Technical issues at stake 22

23 Are Eurocode and ISBT 128 coding systems compatible? 23

24 Are Eurocode and ISBT 128 coding systems compatible? 24

25 The JACIE vs Eurocode case two coding systems with different objectives purpose of the SEC is to achieve harmonisation across disparate coding systems such that an EU tissue or cell product can be traced back to the source establishment purpose of ISBT 128 is to achieve global standardisation of coding and labelling for medicinal products of human origin in order to enhance safety but all of the information in the SEC can be derived from the information held in ISBT 128 barcodes with the exception of the ISO Country Identifier and the source establishment Code ICCBBA provides reference tables that will allow a computer system to derive the entire SEC from the ISBT 128 electronically readable information For those establishments not yet using ISBT 128, this would be the ideal time to introduce the standard: many of the changes required for the SEC will involve similar process steps to those required to introduce ISBT 128 and both time and effort could be saved by combining the activities 25

26 The JACIE vs Eurocode case 26

27 6th Element Unique numeric or alphanumeric identifier Proper name of product Product attributes Recipient name and/or identifier Identity and address of collection facility or donor registry Date, time collection ends, and (if applicable) time zone Approximate volume Name and quantity of anticoagulant and other additives 6th 6th 6th 6th Partial label Label at compl etion of collec tion Label at compl etion of proce ssing Label at distrib ution for admin istrati on 5th Element AF AF AF AF Unique numeric or alphanumeric identifier AF AF AF AF Proper name of product AC AC Product modifiers Product attributes (manipulations) AT AT AT Recipient name and identifier (if applicable) AT AC AC Identity and address of collection facility or donor registry AT AC AC Date, time collection ends, and (if applicable) time zone AT AT AT Approximate volume AC AC AC Name and volume or concentration of anticoagulant and other additives 5th 5th 5th 5th Partial label Label at compl etion of collec tion Label at compl etion of proce ssing Label at distrib ution for admin istrati on AF AF AF AF AF AF AF AF AF AF AF AC AC AF AT AT AT AT AC AC AT AC AC AT AT AT AT AT AT 27

28 6th Element Unique numeric or alphanumeric identifier Proper name of product Product attributes Recipient name and/or identifier Identity and address of collection facility or donor registry Date, time collection ends, and (if applicable) time zone Approximate volume Name and quantity of anticoagulant and other additives 6th 6th 6th 6th Partial label Label at compl etion of collec tion Label at compl etion of proce ssing Label at distrib ution for admin istrati on 5th Element AF AF AF AF Unique numeric or alphanumeric identifier AF AF AF AF Proper name of product AC AC Product modifiers Product attributes (manipulations) AT AT AT Recipient name and identifier (if applicable) AT AC AC Identity and address of collection facility or donor registry AT AC AC Date, time collection ends, and (if applicable) time zone AT AT AT Approximate volume AC AC AC Name and volume or concentration of anticoagulant and other additives 5th 5th 5th 5th Partial label Label at compl etion of collec tion Label at compl etion of proce ssing Label at distrib ution for admin istrati on AF AF AF AF AF AF AF AF AF AF AF AC AC AF AT AT AT AT AC AC AT AC AC AT AT AT AT AT AT 28

29 Acknowledgements Cellular Therapy Standards Committee Leadership Joseph Schwartz Chair Phyllis Warkentin Co-Chair John Snowden - Co-Chair Carolyn Keever-Taylor Past Chair Clinical Subcommittee Rafael Duarte Co-Chair Phillip McCarthy Co-Chair Ahmad Samer Al-Homsi Tiene Bauters Monica Bhatia Colleen Brown Desiree Caselli Mairead ni Chongaile Dennis Confer Patrick John Hayden Hans-Jochem Kolb Kim Orchard Demetrios Petropoulos Tuula Rintala Donna Salzman Kim Schmit-Pokorny Bronwen Shaw Connie Adams Sizemore Koen Theunissen David Vesole Collection Subcommittee Jennifer Anderson Jorg Halter Co-Chair Marie Maningo-Salinas Co- Chair Christopher Chun Maria Custodio Chitra Hosing Pavel Jindra Miguel Lozano Lynn Manson Sheryl McDiarmid John Miller Aurora Vassanelli Hans Vrielink Nina Worel Staff Eoin McGrath Lisa Hoiudesheldt Andra Moehring Kara Wacker Processing Subcommittee Christian Chabannon Co- Chair Richard Meagher Co-Chair Lizette Caballero Paul Eldridge Andreas Humpe William Janssen Ann Kemp Lawrence Lamb Ineke Slaper-Cortenbach Karen Snow Beate Wagner Claire Wiggins Isabel Barbosa 29

30 The future.... looks bright... although hazy! 30