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Good Laboratory Practice
Program Topics
EPA's Good Laboratory Practice Standards (GLPs) compliance monitoring program, through laboratory inspections and data audits, assures the quality and integrity of test data submitted to the Agency under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Toxic Substances Control Act (TSCA). This data is used by the Agency to regulate pesticides and industrial chemicals.
The GLP Advisories interpret the GLP regulations (40 CFR part 160 for FIFRA and 40 CFR part 792 for TSCA). EPA's Agriculture Division of the Office of Compliance, which administers the GLP program, issues the interpretations.
GLP Regulations Advisory No. 81 - (4/15/98)
Test substance storage containers 40 CFR 160.105(c) exception
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory81.pdf (PDF) (16KB)
GLP Regulations Advisory No. 80 - (4/9/98)
Characterization of test substances to determine chemical and physical characteristics ((((ADVISORY HAS BEEN WITHDRAW AND DISTRIBUTION CEASED))))))
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory80.pdf (PDF) (10KB)
GLP Regulations Advisory No. 79 - (12/18/97)
GLPS compliance statement for interim reports (40 CFR 160.12)
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory79.pdf (PDF) (11KB)
GLP Regulations Advisory No. 78 - (8/7/97)
Retention of test substance containers (40CFR 160.105(c))
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory78.pdf (PDF) (18KB)
GLP Regulations Advisory No. 75 - (9/16/96)
Archive of records of out of business companies
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory75.pdf (PDF) (14KB)
GLP Regulations Advisory No. 76 - (9/16/96)
Raw data retention periods for TSCA/GLPs
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory76.pdf (PDF) (16KB)
GLP Regulations Advisory No. 77 - (9/16/96)
Storage stability studies (40CFR 160.135(a)/40 CFR160.135(b) )
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory77.pdf (PDF) (12KB)
GLP Regulations Advisory No. 74 - (7/11/96)
Retention of empty storage containers - excessive numbers thereof
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory74.pdf (PDF) (20KB)
GLP Regulations Advisory No. 73 - (5/17/95)
GLP requirement to assign a study director
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory73.pdf (PDF) (17KB)
GLP Regulations Advisory No. 72 - (7/5/94)
Use of management as technicians in studies by small companies
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory72.pdf (PDF) (15KB)
GLP Regulations Advisory No. 71 - (4/13/94)
Compliance statement a submission & not a final report required
Terminated study reporting requirements
Amended compliance statement as a correction in final report
Inaccuracy of compliance statement
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory71.pdf (PDF) (19KB)
GLP Regulations Advisory No. 70 - (4/6/94)
Final reporting of tests ruled invalid
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory70.pdf (PDF) (17KB)
GLP Regulations Advisory No. 68 - (10/29/93)
Clarification of reporting protocols by QAU inspections
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory68.pdf (PDF) (15KB)
GLP Regulations Advisory No. 67 - (10/21/93)
Test substance storage containers
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory67.pdf (PDF) (18KB)
GLP Regulations Advisory No. 66 - (10/14/93)
Clarification of Advisories 52 and 59
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory66.pdf (PDF) (16KB)
GLP Regulations Advisory No. 63 - (8/3/93)
Disposition of used test substance containers
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory63.pdf (PDF) (18KB)
GLP Regulations Advisory No. 64 - (8/3/93)
Performance of characterization as separates or parts of
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory64.pdf (PDF) (16KB)
GLP Regulations Advisory No. 65 - (8/3/93)
Characterization of test substances and mixtures
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory65.pdf (PDF) (18KB)
GLP Regulations Advisory No. 62 - (6/28/93)
Test substance container retention and surplus substance use.
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory62.pdf (PDF) (17KB)
GLP Regulations Advisory No. 59 - (6/10/93)
CEO/President serving as Study Director
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory59.pdf (PDF) (19KB)
GLP Regulations Advisory No. 60 - (6/10/93)
Retention of original storage containers
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory60.pdf (PDF)
GLP Regulations Advisory No. 61 - (6/10/93)
Archiving wet samples for extended periods
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory61.pdf (PDF) (17KB)
GLP Regulations Advisory No. 58 - (1/29/93)
FIFRA GLPS Compliance by Interregional Research Project No. 4
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory58.pdf (PDF) (16KB)
GLP Regulations Advisory No. 57 - (1/7/93)
Raw old study data retention for new study
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory57.pdf (PDF) (16KB)
GLP Regulations Advisory No. 56 - (1/6/93)
Test material storage requirements
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory56.pdf (PDF) (18KB)
GLP Regulations Advisory No. 69 - (1/1/93)
Internal EPA not for general public use (Marketing permission)
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory69.pdf (PDF) (5KB)
GLP Regulations Advisory No. 55 - (12/4/92)
Test, control and reference substance characterization
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory55.pdf (PDF) (18KB)
GLP Regulations Advisory No. 53 - (11/24/92)
Signature and date thereof on final report
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory53.pdf (PDF) (15KB)
GLP Regulations Advisory No. 54 - (11/24/92)
Archiving requirements
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory54.pdf (PDF) (16KB)
GLP Regulations Advisory No. 52 - (10/16/92)
Quality Assurance Unit function
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory52.pdf (PDF) (17KB)
GLP Regulations Advisory No. 51 - (9/17/92)
Test substance container storage
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory51.pdf (PDF) (17KB)
GLP Regulations Advisory No. 50 - (8/10/92)
Test sample substance retention
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory50.pdf (PDF) (33KB)
GLP Regulations Advisory No. 49 - (6/22/92)
Multi-testing reporting requirements
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory49.pdf (PDF) (35KB)
GLP Regulations Advisory No. 48 - (6/15/92)
Quality Assurance Unit's responsibilities
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory48.pdf (PDF) (31KB)
GLP Regulations Advisory No. 47 - (5/26/92)
Self-carbonized copies for exact copies
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory47.pdf (PDF) (31KB)
GLP Regulations Advisory No. 44 - (5/5/92)
Archiving of raw data
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory44.pdf (PDF) (33KB)
GLP Regulations Advisory No. 45 - (5/5/92)
Test substance definition
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory45.pdf (PDF) (33KB)
GLP Regulations Advisory No. 46 - (5/5/92)
Test facility definition
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory46.pdf (PDF) (33KB)
GLP Regulations Advisory No. 43 - (3/3/92)
One trial one location
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory43.pdf (PDF) (32KB)
GLP Regulations Advisory No. 42 - (1/22/92)
Archiving requirements - number of reports/protocols.
Reference and control substances characterization
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory42.pdf (PDF) (37KB)
GLP Regulations Advisory No. 41 - (1/21/92)
Test substance container storage
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory41.pdf (PDF) (34KB)
GLP Regulations Advisory No. 40 - (1/15/92)
Test substance container storage
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory40.pdf
GLP Regulations Advisory No. 39 - (1/13/92)
Generic protocol
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory39.pdf (PDF) (16KB)
GLP Regulations Advisory No. 38 - (12/4/91)
Responsibility of archive
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory38.pdf (PDF) (14KB)
GLP Regulations Advisory No. 37 - (11/1/91)
Maintenance of test substance container storage
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory37.pdf (PDF) (15KB)
GLP Regulations Advisory No. 31 - (6/28/91)
Archive of records-time/location/duration of study
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory31.pdf (PDF) (24KB)
GLP Regulations Advisory No. 32 - (6/28/91)
Analysis of test substance mixture
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory32.pdf (PDF) (18KB)
GLP Regulations Advisory No. 33 - (6/28/91)
Method revalidation compliance
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory33.pdf (PDF) (16KB)
GLP Regulations Advisory No. 34 - (6/28/91)
Number of compliance statements and QA reports
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory34.pdf (PDF) (17KB)
GLP Regulations Advisory No. 35 - (6/28/91)
Retention of raw data
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory35.pdf (PDF) (17KB)
GLP Regulations Advisory No. 36 - (6/28/91)
Retention time of wet specimens
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory36.pdf (PDF) (150KB)
GLP Regulations Advisory No. 24 - (12/4/90)
Test substance container storage
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory24.pdf (PDF) (34KB)
GLP Regulations Advisory No. 25 - (12/4/90)
Test substance container storage
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory25.pdf (PDF) (18KB)
GLP Regulations Advisory No. 26 - (12/4/90)
Test substance container storage
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory26.pdf (PDF) (19KB)
GLP Regulations Advisory No. 27 - (12/4/90)
Test substance container storage
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory27.pdf (PDF) (16KB)
GLP Regulations Advisory No. 28 - (12/4/90)
Efficacy studies compliance
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory28.pdf (PDF) (24KB)
GLP Regulations Advisory No. 29 - (12/4/90)
Exploratory studies compliance
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory29.pdf (PDF) (16KB)
GLP Regulations Advisory No. 30 - (12/4/90)
Analysis of test substance mixture
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory30.pdf (PDF) (23KB)
GLP Regulations Advisory No. 23 - (11/7/90)
Test substance storage stability
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory23.pdf (PDF) (16KB)
GLP Regulations Advisory No. 21 - (11/1/90)
Storage of test substance mixed with carrier
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory21.pdf (PDF) (17KB)
GLP Regulations Advisory No. 22 - (11/1/90)
Study Director number per study
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory22.pdf (PDF) (16KB)
GPL Regulations Advisory No. 15 - (7/16/90)
Off site location of study director/QAU
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory15.pdf (PDF) (33KB)
GLP Regulations Advisory No. 14 - (6/11/90)
Compliance of confirmatory method trials
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory14.pdf (PDF) (42KB)
GLP Regulations Advisory No. 13 - (5/1/90)
Frequency of QA audits at multiple test sites
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory13.pdf (PDF) (42KB)
GLP Regulations Advisory No. 12 - (4/12/90)
Off-site archives
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory12.pdf (PDF) (43KB)
GLP Regulations Advisory No. 11 - (4/10/90)
Compliance of test substance synthesis
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory11.pdf (PDF) (31KB)
GLP Regulations Advisory No. 05 - (3/22/90)
Container storage maintenance
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory05.pdf (PDF) (26KB)
GLP Regulations Advisory No. 03 - (12/20/89)
Frequency of QA Inspections
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory03.pdf (PDF) (32KB)
GLP Regulations Advisory No. 04 - (12/20/89)
Study Director/Test Facility, Number per study
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory04.pdf (PDF) (33KB)
GLP Regulations Advisory No. 06 - (12/20/89)
Study Director number per study
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory06.pdf (PDF) (27KB)
GLP Regulations Advisory No. 07 - (12/20/89)
Retention of soil samples
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory07.pdf (PDF) (23KB)
GLP Regulations Advisory No. 08 - (12/20/89)
Study Director number per study
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory01.pdf (PDF) (26KB)
GLP Regulations Advisory No. 09 - (12/20/89)
Retention time for wet specimens Number of signatures on compliance statement.
Test substance metabolites listed in protocol
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory09.pdf (PDF) (35KB)
GLP Regulations Advisory No. 10 - (12/20/89)
Compliance of test substance synthesis
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory10.pdf (PDF) (32KB)
GLP Regulations Advisory No. 02 - (12/20/89)
Samples, retention time, schedules
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory02.pdf (PDF) (31KB)
GLP Regulations Advisory No. 01 - (6/1/89)
Solubility Studies
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory01.pdf (PDF) (34KB)
GLP Regulations Advisory No. 16 - (1/1/89)
Retention of reserve test substance samples
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory16.pdf (PDF) (30KB)
GLP Regulations Advisory No. 17 - (1/1/89)
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory17.pdf (PDF) (41KB)
GLP Regulations Advisory No. 18 - (1/1/89)
Study protocol, number per study
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory18.pdf (PDF) (30KB)
GLP Regulations Advisory No. 19 - (1/1/89)
General questions on GLP interpretation
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory19.pdf (PDF) (29KB)
GLP Regulations Advisory No. 20 - (1/1/89)
Number of study directors per study
http://www.epa.gov/compliance/resources/policies/monitoring/glp/advisory20.pdf (PDF) (42KB)
Standard Operating Procedures (SOPs)
Search the SOPs used by EPA when conducting GLP inspections and data audits.
GLP-DA-06 Auditing Antimicrobial Efficacy Studies - (6/16/99)
http://www.epa.gov/compliance/resources/policies/monitoring/sop/glp-da-06.pdf (PDF) (40KB)
GLP-C-02 Determining Compliance of Audited Studies with GLP - (6/9/99)
http://www.epa.gov/compliance/resources/policies/monitoring/sop/glp-c-02.pdf (PDF) (71KB)
GLP-DA-11 Auditing Reproductive/Developmental Toxicology Studies - (6/9/99)
http://www.epa.gov/compliance/resources/policies/monitoring/sop/glp-da-11.pdf (PDF) (27KB)
GLP-DA-02 Auditing Ecotoxicology Studies - (6/8/99)
http://www.epa.gov/compliance/resources/policies/monitoring/sop/glp-da-02.pdf (PDF) (20KB)
GLP-C-01 Conducting a Field Studies GLP Compliance Inspection - (6/7/99)
GLP-C-01 Conducting a Field Studies GLP Compliance Inspection
http://www.epa.gov/compliance/resources/policies/monitoring/sop/glp-c-01.pdf (PDF) (65KB)
GLP-DA-01 Auditing Field Studies (Analytical Chemistry) - (6/7/99)
http://www.epa.gov/compliance/resources/policies/monitoring/sop/glp-da-01.pdf (PDF) (39KB)
GLP-DA-03 Auditing Insecticide Efficacy Studies - (6/7/99)
http://www.epa.gov/compliance/resources/policies/monitoring/sop/glp-da-03.pdf (PDF) (17KB)
GLP-DA-07 Auditing Nature and Magnitude of the Residue in Livestock Studies (Biology Portions) - (6/7/99)
http://www.epa.gov/compliance/resources/policies/monitoring/sop/glp-da-07.pdf (PDF) (22KB)
GLP-DA-08 Auditing Pathology Data - (6/7/99)
http://www.epa.gov/compliance/resources/policies/monitoring/sop/glp-da-08.pdf (PDF) (29KB)
GLP-DA-09 Auditing General Toxicology Studies - (6/7/99)
http://www.epa.gov/compliance/resources/policies/monitoring/sop/glp-da-09.pdf (PDF) (29KB)
GLP-DA-10 Auditing Genetic Toxicology Studies - (6/7/99)
http://www.epa.gov/compliance/resources/policies/monitoring/sop/glp-da-10.pdf (PDF) (30KB)
GLP-DA-13 Auditing Human Patch Studies - (6/7/99)
http://www.epa.gov/compliance/resources/policies/monitoring/sop/glp-da-13.pdf (PDF) (16KB)
GLP-S-05 Glossary of GLP and Selected EPA Terms and Acronyms - (6/7/99)
http://www.epa.gov/compliance/resources/policies/monitoring/sop/glp-s-05.pdf (PDF) (82KB)
GLP-DA-04 Auditing Residue and Environmental Fate Studies (Field Portions) - (6/6/99)
http://www.epa.gov/compliance/resources/policies/monitoring/sop/glp-da-04.pdf
GLP-C-04 Compliance Review of Biotechnology Facilities - (1/4/99)
http://www.epa.gov/compliance/resources/policies/monitoring/sop/glp-c-04.pdf (PDF) (208KB)