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Source Plasma Labeling

Source Plasma Labeling. Judy Ellen Ciaraldi BS, MT(ASCP)SBB, CQA(ASQ) CBER, OBRR, DBA September 16, 2009. Outline . Source Plasma label regulations Common information on all Source Plasma labels Source Plasma for manufacturing into injectable products

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Source Plasma Labeling

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  1. Source Plasma Labeling Judy Ellen Ciaraldi BS, MT(ASCP)SBB, CQA(ASQ) CBER, OBRR, DBA September 16, 2009

  2. Outline • Source Plasma label regulations • Common information on all Source Plasma labels • Source Plasma for manufacturing into injectable products • Source Plasma for manufacturing into noninjectable products • Source Plasma Salvaged • How to submit Source Plasma labels • Source Plasma label review

  3. SP Labeling Regulations • Applicable regulations • 21 CFR 610.40 • 21 CFR 610.62 • 21 CFR 640.70 • 21 CFR 640.76 • Non-applicable regulations • 21 CFR 606.121 – Donor classification, machine-readable • 21 CFR 606.122 – Instruction circular • 21 CFR 610.60 – Information contained in 640.70 • 21 CFR 610.61 – Package label

  4. Info on all SP Labels • Proper name of the product, i.e. Source Plasma (640.60) • Prominent position and size • Legible type • Caution statement • Follow proper name of the product • Same size and type as proper name • Storage temperature • Total volume or weight of product • Anticoagulant name and volume

  5. Info on all SP Labels (cont.) • Donor or bleed number • Trace unit to donor and donor’s records • Pools – all donor or bleed numbers or a pool number • Expiration date • 10 years • Pools – determined by collection date of oldest unit • Collection method • Manual method • Automated method

  6. Info on all SP Labels (cont.) • Type of donor • Normal donor • Pre-existing disease associated antibody • Immunized donor – state immunizing antigen • Disease state donor • High-risk donor • Name, address and license number • Legal entity name (vs. “dba” name) • Plasma center or corporate address • Street and city/state or only city/state address

  7. Info on all SP Labels (cont.) • Infectious disease test results • List results for tests that are completed • Identify which tests are pending • Negative/nonreactive test results • “Negative by tests for antibody to HIV and HCV and nonreactive for HBsAg, HCV RNA and HIV-1 RNA ” or equivalent • Positive/reactive test results • Identify which tests are positive/reactive • Biohazard symbol on unit • Identify if collected from donor with previous positive/reactive test

  8. SP for Injectable Products • Caution statement • “CAUTION: FOR FURTHER MANUFACTURING USE ONLY” • Storage temperature • -20 C or colder

  9. SP for Noninjectable Products • An appropriate caution statement • “CAUTION: FOR USE IN MANUFACTURING NONINJECTABLE PRODUCTS ONLY” • “CAUTION: FOR FURTHER MANUFACTURING INTO IN VITRO DIAGNOSTIC REAGENTS FOR WHICH THERE ARE NO ALTERNATIVE SOURCES”* • “CAUTION: FOR LABORATORY RESEARCH USE ONLY” • *Positive/reactive test results • Storage temperature • Appropriate for final product, determined by consignee

  10. SP for Noninjectable Products (cont.) • Anti-HBc statement • Not tested for anti-HBc • Negative for anti-HBc • Reactive for anti-HBc • FDA Recommendations Concerning Testing for Antibody to Hepatitis B Core Antigen (Anti-HBc) (9/10/91) • Reactive for syphilis test • “Reactive by a Serological Test for Syphilis” • “Use Only for Manufacturing Positive Control Reagents for Serological Tests for Syphilis”

  11. Source Plasma Salvaged • Relabeling if SP intended for injectable products is exposed to unacceptable temperatures • Not required when • Only 1 episode of storage warmer than -20 C and colder than -5 C for less than 72 hours and units remained solid • Required when • > 1 inadvertent exposure during storage of warmer than -20 C and colder than +10 C for not more than 72 hours • > 1 inadvertent exposure during shipping of warmer than -5 C and colder than +10 C for not more than 72 hours • Additional statements when relabeling • “STORAGE TEMPERATURE EXCEEDED -20 C” • “SHIPPING TEMPERATURE EXCEEDED -5 C”

  12. Submitting SP Labels • Original BLA or BLA supplement for specific collection program • Label for each collection program • Original and copy of each label • Forms 356h and FDA-2567: Transmittal of Labels and Circulars • Reporting category based on collection program • 21 CFR 601.12(f)(1) - PAS • 21 CFR 601.12(f)(2) - CBE

  13. Reviewing SP Labels • Based on regulations and guidance documents • Documented on label review checklist • Branch chief concurrence • Label review checklist with decision sent to applicant • Approved • Approved with comments - revise on next printing or software upgrade • Not approved – revise and submit

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