当前位置：资源分享 > GLP
1.Advisory/Policy: GLP Regulations Advisories, issued by the EPA Policy and Grants Division.
2.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.
3.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.
4.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)
5.Advisory/Policy 1991: http://www.fda.gov/ICECI/EnforcementActions/ApplicationIntegrityPolicy/ucm134741.htm
6.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.
7.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.
8.FDA Bioresearch Compliance Program Guidance Manual, February 21, 2001: http://www.fda.gov/ICECI/EnforcementActions/BioresearchMonitoring/ucm133789.htm
9.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/
10.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/
11.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/
12.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
13.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).
14.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
15.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.
16.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.
17.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.
18.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.
19.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.
20.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.
21.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.
22.药物非临床研究质量管理规范 国家食品药品监督管理总局令 第34号 自2017年9月1日起施行http://www.nmpa.gov.cn/WS04/CL2174/300695.html