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.
- 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
- Advisory/Policy 1993: https://www.epa.gov/system/files/documents/2021-12/glpinspectionmanual.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
- Advisory/Policy 1992: https://nepis.epa.gov/Exe/ZyPDF.cgi/9100M94N.PDF?Dockey=9100M94N.PDF
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
- Advisory/Policy 1991: https://www.epa.gov/sites/default/files/documents/fifraglperp-093091.pdf
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
- 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
- Advisory/Policy 1991: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/application-integrity-policy/fr-fda-091091-notice-56-fr-46191-fraud-untrue-statements-material-facts-bribery-and-illegal
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.
- Good Laboratory Practice (GLP), Amendment, Final Rule, 9/4/1987:
https://www.fda.gov/media/75860/download
- Good Laboratory Practice (GLP), Proposed Rule, 10/29/1984:
https://www.fda.gov/media/75849/download
- 1981 Question and Answer:
https://www.fda.gov/media/75866/download
- 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
- Good Laboratory Practice Regulations Management Briefings, Post Conference Report, Aug 1979:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/good-laboratory-practice-regulations-management-briefings-post-conference-report-aug-1979
- Preamble 1978:
https://archives.federalregister.gov/issue_slice/1978/12/22/59967-60019.pdf
- FDA Bioresearch Compliance Program Guidance Manual, May 1, 2018:
https://www.fda.gov/media/75891/download
Program 7348.808
Good Laboratory Practices for Non-Clinical Laboratory Studies
US Food and Drug Administration
- 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
https://research.uga.edu/quality-assurance/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.
- US/CFR most current version plus preambles from all versions Good Laboratory Practice Standards (FIFRA); Title 40, Part 160, Code of Federal Regulations.
Regulations: https://research.uga.edu/quality-assurance/glps/epa/ OR https://www.ecfr.gov/current/title-40/chapter-I/subchapter-E/part-160
FIFRA Q&A: https://research.uga.edu/quality-assurance/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.
- US/CFR most current version plus preambles from all versions Good Laboratory Practice Standards (TSCA); Title 40, Part 792, Code of Federal Regulations.
Regulations: https://research.uga.edu/quality-assurance/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.
- 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, advisories, and position papers, can be accessed from the following site:
https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm
Or via mail at:
OECD Environment Directorate
Environmental Health and Safety Division
2 rue André-Pascal
75775 Paris Cedex 16, France