Challenges In Cell Product Labeling, Tracking And Traceability

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1 Challenges In Cell Product Labeling, Tracking And Traceability April 4-5, 2008 Columbus, Ohio Dave Krugh, MT(ASCP)SBB, CLS,CLCP(NCA) Clinical Program Manager, BMT Program Clinical Instructor, Department of Pathology, College of Medicine and Public Health

2 James Cancer Hospital And Solove Research Institute BMT Program AABB, CAP, FACT, TJC Accredited

3 Labeling, Tracking And Traceability In Review 1970 s allogeneic BMT: name of donor and patient Early 1980 s autologous BMT: patient name, social security number or medical record number 1987: NMDP developed unique number handwritten on label (1 and 7) 1989: ISBT : National Drug Code number (21 CFR ) More than minimally manipulated Unrelated donors 2005: GTP Hematopoietic Stem Cells 2002: Hematopoietic Progenitor Cells FACT: Human Peripheral Blood Hematopoietic Progenitor Cells 2005 COI: HPC Dr. E Donnall Thomas

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5 FDA (21 CFR 1271) Labeling , , , SOP HCT/P identification (no patient name, social security number or medical record number; exception autologous, 1 st /2 nd degree relatives) System to prevent mix-ups Verification of accuracy, legibility and integrity Process control, change control and validation Retain 10 years. Quarantine Quality audits Labeling is a core cgtp Documentation HCT/P deviations CAPA

6 FDA (21 CFR 1271) Labeling , , , Label (appear) Information clearly and accurately HCT/P identification Description of type HCT/P Expiration date, if any Necessary WARNINGS Label (appear or accompany) Name and address of establishment determined donor eligibility and made HCT/P for distribution Storage temperature Instructions for use when related to the prevention of, the identification, transmission or spread of communicable disease

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11 AABB Labeling 2 nd Edition Standards For Cellular Therapy Products SOP Acquisition and creation of label templates Qualification, review and approval Verification label stock meets facility defined specifications Verification labeling Procurement Receipt processing facility Facility defined in process steps Completion of processing and before storage Before distribution Before administration

12 AABB Labeling 2 nd Edition Standards For Cellular Therapy Products SOP HCT/P identification System for discard of obsolete labels Archived 10 years Label in proximity of donor Circular of information Biohazard label List of labels Shipping container Positive identification Appropriate handling Label toxic or volatile packing material

13 Affix, Attach, Accompany AABB Terminology Labeling: information that is required or selected to accompany a cellular therapy product, which may include content, identification, description of processes, storage requirements, expiration date, cautionary statements, and/or indications for use Tracking: to follow all steps of a process or procedure from beginning to end

14 Affix, Attach, Accompany AABB Terminology P: permanently affix (21 CFR 175) A: affixed or attached using a tie-tag If affixing the applicable warnings and statements to the container is physically impossible, then the labeling must accompany the HCT/P R: accompanying records Label: an inscription affixed to a product for identification

15 CAP Labeling October 2006 Transfusion Medicine Checklist SOP Labeling system HCT/P identification Label Autologous Use Only Biohazard label Do Not Irradiate Circular of Information Allogeneic cell product must not receive final and complete labeling until all requirements have been satisfied and complete

16 FACT Labeling 3 rd Edition Accreditation Manual Quality Management Plan Documentation and product labeling Label control (e.g., obsolete labels) Verification of labels Inventory control Quality audits SOP Ordering, receipt, quarantine and verification Prevent mislabeling or misidentification (e.g., checks, designated labeling area) Unused labels stored controlled manner Obsolete labels destroyed

17 FACT Labeling 3 rd Edition Accreditation Manual SOP Version control Transferring and verification of information (e.g., modifications to label) Label affixed to allow inspection ALL data fields complete (N/A or none) Labeling proximity of donor Elements comply with applicable governmental regulations Cell product repackaged into new container, new labels Copies of current label versions Quarantine

18 FACT Labeling 3 rd Edition Accreditation Manual Label HCT/P identification Supplementary ID not obscure original ID Facility identification for each HCT/P identifier Inappropriate to label ABO/Rh based on historical results Held upon receipt review and proofing against copy or template Print on demand review and proofing against a copy or template

19 FACT Labeling 3 rd Edition Accreditation Manual Label Archived 10 years with inclusive dates of use Clear, legible, indelible ink Validated reliable for storage Applicable warnings and biohazard label Autologous donor and donor eligibility NOT determined: not evaluated for infectious substances Allogeneic donor add warning: advise patient of communicable disease risk

20 FACT Labeling 3 rd Edition Accreditation Manual Shipping Container Inner container Outer container Partial label HCT/P identification Proper HCT/P name HCT/P modifiers Name and identification of intended recipient

21 Affix, Attach, Accompany FACT AF: affix Terminology To attach in physical contact with the cellular therapy product container AT: attach or affix To fasten securely to the cellular therapy product container by means of a tie tag or comparable alternative; any information required to be attached to a container may alternatively be affixed AC: accompany, attach or affix To go or to be together with but not attached; information that must accompany a cellular therapy product in a sealed package, or alternatively, be attached or affixed.

22 Affix, Attach, Accompany FACT Terminology Labeling: steps taken to identify the original cellular therapy product collection and any products or product modifications; to complete the required reviews; and to attach the appropriate labels Partial Label: the minimum essential elements that must be affixed to all cellular therapy product containers. Track: to follow a process or product from beginning to end Trace: to follow the history of a process, product, or service by review of documents

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24 Label Challenges Design Base label or tie tag Apply directly Approval of label proof Reproduction Print on demand Xerox Computer generated Manufacturer Qualification of supplier Validation Manufacturing or printing defects Correct version Legible and correct Identity to label proof

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28 Label Challenges Quality control Conditions of storage Curl back, adhesion Legible Alterations Label placement Label control/tracking Version control Change control Obsolete labels

29 Compare And Merge

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31 Contact Information or QUESTIONS