RQAP-GLP Examination Study References

The following is a listing of suggested Quality Assurance references. This list is not all-inclusive and candidates should not limit their study to only those references listed below. Candidates are also encouraged to study all historic and current preambles in addition to the current regulations, where applicable. This listing was extracted from the “Bibliography of Quality Assurance References” published in 1999 by the SQA.
 

  1. Advisory/Policy: GLP Regulations Advisories, issued by the EPA Policy and Grants Division.
        Compliance Monitoring
        Quality Assurance
        Retention
        Storage
        Study Archive
        Study Director
     
    US Environmental Protection Agency (EPA)
    Laboratory Data Integrity Assurance Division
    2805 Jefferson Davis Highway
    Arlington, VA 22202
     
  2. Advisory/Policy 1993: http://www.sqa.org/uploadedFiles/SQA_Home/professional-registration/GLP.StudyRef2.EPA-GLP-StandardsInspManual.pdf

    Good Laboratory Practice Standards Inspection Manual. A manual that provides EPA inspectors with guidance in conducting GLP inspections under both FIFRA and TSCA. EPA number 723-B-93-001.

    EPA/OPPTS
    Office of Prevention, Pesticides, and Toxic Substances
    US Environmental Protection Agency
    Washington, DC 20460
     
  3. Advisory/Policy 1992: http://www.ovpr.uga.edu/qau/resources/glps/fifra/ 

    FIFRA Good Laboratory Practice Standards (GLPs) Regulations Questions and Answers Document. This 14-page document consists of responses made by the Office of Compliance Monitoring in past correspondence to members of the regulated community. It was prepared by the Policy and Grants Division of the Office of Compliance and was released on May 12, 1992.

    Office of Compliance Monitoring
    Office of Prevention, Pesticides, and Toxic Substances
    US Environmental Protection Agency
    Washington, DC 20460
     
  4. Advisory/Policy 1991: http://www2.epa.gov/enforcement/enforcement-response-policy-erp-federal-insecticide-fungicide-and-rodenticide-act-fifra

    Enforcement Response Policy for the Federal Insecticide, Fungicide, and Rodenticide Good Laboratory Practice (GLP) Regulations. This publication describes liabilities, fines and procedures for violations of the FIFRA GLPs; it was effective as of September 30, 1991.

    Pesticide Enforcement Policy Branch
    Office of Compliance Monitoring
    Office of Prevention, Pesticides, and Toxic Substances
    US Environmental Protection Agency
    401 M Street, SW, EN-342W
    Washington, DC 20460
     
  5. Advisory/Policy 1991:http://www.fda.gov/ICECI/EnforcementActions/ApplicationIntegrityPolicy/ucm134744.htm

    Points to Consider for Internal Reviews and Corrective Action Operating Plans, US Food and Drug Administration. This publication describes actions that applicants may take to affirm the validity of data that have been called into question by the FDA. Relates to FDA’s Compliance Policy Guide 7150.09 on “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities (final policy).” $17 (paper), $9 (MICROFICHE)

    National Technical Information Service (NTIS), Publication Number PB91-228106

    US Department of Commerce, NTIS
    5285 Port Royal Road
    Springfield, VA 22161
     
  6. Advisory/Policy 1991: http://www.fda.gov/ICECI/EnforcementActions/ApplicationIntegrityPolicy/ucm134741.htm

    Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities; Final Policy.
    US Food and Drug Administration (FDA)
    Federal Register 56:46191-46200, September 10, 1991.

    This publication sets forth the FDA’s general approach regarding applicants who seek to subvert the FDA’s review and approval process for premarket applications.
     
  7. Advisory/Questions 1981: 
    http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070282.pdf

    Good Laboratory Practice Regulations: Questions and Answers. [Part II], Lepore, P.D. Ask for the most recent version. Must order by letter or by fax. Be specific about records required. Include you name, address and phone number. Specify the maximum dollar amount you are willing to be billed, and request a letter if the total will exceed that amount. FOI will send a bill. Do not sent money.

    FDA Freedom of Information Office (FOI)
    Food and Drug Administration, (HFI-35)
    5600 Fishers Lane
    Rockville, MD 20857
     
  8. Advisory/Questions 1979: 
    http://www.sqa.org/docs/RQAP/FDA GLP Management briefings 1979.pdf

    Good Regulatory Practice Regulations: Questions and Answers. Subpart B. [Part I], Lepore, P.D. Good Laboratory Practices Regulations Management Briefings - Post Conference Report. Ask for the most recent version.

    FDA Freedom of Information Office
    Food and Drug Administration, (HFI-35)
    5600 Fishers Lane
    Rockville, MD 20857
     
  9. FDA Bioresearch Compliance Program Guidance Manual, February 21, 2001: 
    http://www.fda.gov/ICECI/EnforcementActions/BioresearchMonitoring/ucm133789.htm

    Program 7348.808
    Good Laboratory Practices for Non-Clinical Laboratory Studies
    US Food and Drug Administration
     
  10. Regulations - US/CFR most current version - Good Laboratory Practices for Non-Clinical Laboratory Studies; Title 21, Part 58, Code of Federal:
    http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=58&showFR=1
    http://www.ovpr.uga.edu/qau/resources/glps/fda/


    US Food and Drug Administration
    US Government Printing Office
    Superintendent of Documents
    Mail Stop: SSOP
    Washington, DC 20402-9328

    The most recent edition of the FDA GLPs as they appear in the CFR.
     
  11. US/CFR most current version plus preambles from all versions Good Laboratory Practice Standards (FIFRA); Title 40, Part 160, Code of Federal Regulations.

    Regulations:  http://www.ovpr.uga.edu/qau/resources/glps/epa/
    FIFRA Q&A (also listed as item 3 above):  http://www.ovpr.uga.edu/qau/resources/glps/fifra/

    US Environmental Protection Agency
    US Government Printing Office
    Superintendent of Documents
    Mail Stop: SSOP
    Washington, DC 20402-9328

    The most recent edition of the EPA FIFRA GLPs as they appear in the CFR.
     
  12. US/CFR most current version plus preambles from all versions Good Laboratory Practice Standards (TSCA); Title 40, Part 792, Code of Federal Regulations.

    Regulations: http://www.ovpr.uga.edu/qau/resources/glps/tsca/ 

    US Environmental Protection Agency
    US Government Printing Office
    Superintendent of Documents
    Mail Stop: SSOP
    Washington, DC 20402-9328

    The most recent edition of the EPA TSCA GLPs as they appear in the CFR.
     
  13. Principles – OECD – most current version. The Organisation for Economic Cooperation and Development Principles of Good Laboratory Practice, ENV/MC/CHEM (98) 17.

    All OECD GLP principles, including guidance/policy and advisories, can be accessed from the following site:

    http://www.oecd.org/document/63/0,2340,en_2649_34381_2346175_1_1_1_1,00.html

    Or via mail at:

    OECD Environment Directorate
    Environmental Health and Safety Division
    2 rue André-Pascal
    75775 Paris Cedex 16, France
     
  14. Guidance/Policy: Guidance for GLP Monitoring Authorities Revised Guidance for the Conduct of Laboratory Inspections and Study Audits – Environment Monograph No. 111, OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring – Number 3 (Revised).
     
  15. Guidance/Policy: Quality Assurance and GLP – Consensus Document, OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring – Number 4 (Revised), ENV/JM/MONO(99)20
     
  16. Guidance/Policy: Compliance of Laboratory Suppliers with GLP Principles – Consensus Document, OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring – Number 5 (Revised), ENV/JM/MONO(99)21.
     
  17. Guidance/Policy: The Application of the GLP Principles to Field Studies – Consensus Document, OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring – Number 6 (Revised), ENV/JM/MONO(99)22.
     
  18. Guidance/Policy: The Application of the GLP Principles to Short Term Studies – Consensus Document, OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring – Number 7 (Revised), ENV/JM/MONO(99)23.
     
  19. Guidance/Policy: The Role and Responsibilities of the Study Director in GLP Studies – Consensus Document, OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring – Number 8 (Revised), ENV/JM/MONO(99)24.
     
  20. Guidance/Policy: The Application of the Principles of GLP to Computerized Systems, Environment Monograph No. 116 – GLP Consensus Document, OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring – Number 10, OCDE/GD(95)115.
     
  21. Guidance/Policy: The Application of the OECD Principles of GLP to the Organization and Management of Multi-Site Studies – Consensus Document of the Working group on Good Laboratory Practice, OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring – Number 13, ENV/JM/MONO(2002)9.
     
  22. Advisory: The Role and Responsibilities of the Sponsor in the Application of the Principles of GLP – Advisory Document of the Panel on Good Laboratory Practice, OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring – Number 11, ENV/MC/CHEM(98)16.
    

CPR Position on RQAP exam Review Courses 

 

Exam Contacts:

SQA Headquarters
154 Hansen Road, Suite 201
Charlottesville, VA 22911
Telephone: +1 434.297.4772
Facsimile: +1 434.977.1856
rqap@sqa.org
 

Council on Professional Registration:
Trisha L Franz RQAP-GLP
GLP Exam Subcommittee Chair
Southwest Bio-Labs Inc
Telephone: +1 806.353.4714
mtmtfranz1@suddenlink.net

  

Testing Services Provider:

Professional Testing, Inc.
301 E. Pine Street, Suite 505
Orlando, FL 32801 USA
Telephone: +1 800.330.3776 (U.S. and Canada)
Telephone: +1 407.264.2993 (International)
Web: www.proftesting.com