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Laboratory of Immunobiochemistry and ISO 17025 Accreditation

Laboratory of Immunobiochemistry and ISO 17025 Accreditation. Sandra Menzies, M.S., Consumer Safety Officer Laboratory of Immunobiochemistry, CBER, FDA . Frye v. Unites States, 1972 Expertise must be generally accepted by the scientific community

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Laboratory of Immunobiochemistry and ISO 17025 Accreditation

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  1. Laboratory of Immunobiochemistry and ISO 17025 Accreditation Sandra Menzies, M.S., Consumer Safety OfficerLaboratory of Immunobiochemistry, CBER, FDA

  2. Frye v. Unites States, 1972 Expertise must be generally accepted by the scientific community Daubert v. Merrill Dow Pharmaeuticals, Inc., 1993 Federal Rules of Evidence Judge determines expert’s testimony: Reliable foundation Relevant to the task Frederic Whithurst, Ph.D. FBI Expert Witness and Whistleblower O.J. Simpson Murder Trial World Trade Center Bombing 1997 OIG Findings Evaluation of 51 cases ID by Dr. Whithurst improper report preparation, insufficient documentation of results, scientifically flawed reports, inadequate records, and unqualified examiners History of Scientific EvidenceNew standards initiated by FBI experience

  3. FDA History Oct. 1998 • FDA’s Senior Science Council (SSC) began to assess lab accreditation Nov. 1999 • FDA Leadership Council and the Commissioner endorsed a proposal from the SSC • each FDA Center and ORA independently pursue accreditation of official testing activities according to individual center needs and activities

  4. Accreditation • Approval that a group has met specific requirements after undergoing an inspection by an accreditation body. • Inspectors are experts in the field in which accreditation is sought. • Accreditation is based on procedures that standardize the accreditation bodies (ISO/IEC 17011).

  5. Laboratory Accreditation • Testing laboratories are: • Competent and • Credible • to specific tests. • Results are: • Accurate, • Reproducible, and • Traceable. • Formal recognition that a testing laboratory is competent to carry out the tests identified within the scope of accreditation • Accreditation ensures that:

  6. Standards Organization • American Society for Testing and Materials (ASTM) International • American National Standards Institute (ANSI) • International Organization for Standards (ISO)

  7. International Organization for Standards (ISO) • ISO based on Greek word isos meaning “equal” • Established in October 1947 • Identifies the global need for international standards • A non-governmental organization • A federation of national standards bodies within 157 countries • The world’s leading developer of International Standards • 18,536 International standards and standard-type documents (as of 12/31/10) • CBER selected ISO 17025 to provide the framework for its laboratory testing program.

  8. ISO 17025 • ISO 17025:2005 “General requirements for the competence of testing and calibration laboratories” • Management requirements • Technical requirements • ISO 17025 formerly called Guide 25 • Allows for recognition of testing laboratory results worldwide • Provides accreditation of defined, validated methods

  9. Managementof a LaboratoryQuality System (LQS)

  10. Testing Life-cycle

  11. Technical Requirements

  12. CBER History Nov. 2001 • FDA recommended that CBER be accredited to ISO 17025 Sept 2006 • Re-organization of CBER’s lot release testing program and establishment of Division of Product Quality (DPQ) March 2009 • Upon determination that allergenic lot release will remain with LIB, LIB initiated LQS development June 2010 • DPQ assessed for ISO 17025 Accreditation by A2LA. Oct. 2010 • DPQ granted ISO 17025 Accreditation (Future) • ISO 17025 Accreditation assessment of LIB

  13. Laboratory Quality System Organization ChartLaboratory of ImmunobiochemistryDivision of Bacterial, Parasitic and Allergenic ProductsOVRR, CBER, USFDA

  14. LIB’s Scope of Accreditation • Competition ELISA • Grass pollens • Mites • Bermuda • Radial Immunodiffusion Assay (RID) or Sandwich ELISA • Ragweed • Cat hair and Cat pelt

  15. LIB’s LQS Status • 63 procedures developed and issued • addresses all areas of the quality system • 12 of these documents are undergoing changes • 7 documents developed but not issued • Equipment maintenance contracts for: • Pipettes • Balances • Method Validation • Ragweed RID – completed • Competition ELISA –testing is on-going • Cat RID – validation protocol in development

  16. LIB’s LQS Status – In process • Authorization of personnel • Equipment qualification • Freezers, refrigerators, cold rooms • Comparing RID viewing calipers • Air handlers • Chemical hoods

  17. Recent Internal Audit • First Quarter 2011 and focused on: • Document Control • Testing Plans • Purchasing of Services and Supplies • Control of Records • Personnel • Accommodation and environmental conditions • Reporting of results • Several minor findings.

  18. Summary • LIB’s continues to develop a LQS that is accreditable to ISO 17025 • Future goals: • Complete the LQS development • Undergo an LQS internal audit • Accreditation assessment • A LQS will provide management with an assurance that data generated by LIB are accurate, reproducible, and traceable.

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