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Good Laboratory Practices - Advisories

FIFRA Topics

The laboratory inspection/data audit program monitors the regulated community, who periodically raise questions related to the interpretation of the Good Laboratory Practices (GLP) regulations. Inspectors and other interested personnel have also asked EPA for guidance on the regulations.   Often the questions are relatively simple and straight forward to which all inspectors would provide a uniform and consistent reply.  However, there are instances when several interpretations are possible or clarification may be necessary. The purpose of the advisories is to provide that clarification.

What follows are interpretations of the GLP regulations as issued by theOffice of Compliance.  This interpretation is official policy in the GLP program and should be followed by all GLP inspectors.

Advisory Topics

You will need Adobe Reader to view some of the files on this page. See EPA's PDF page to learn more.

Compliance Monitoring

GLP Regulations Advisory No. 01 (PDF) (4 pp, 37K) —Solubility studies

GLP Regulations Advisory No. 10 (PDF) (3 pp, 33K)—Compliance of test substance

GLP Regulations Advisory No. 11 (PDF) (2 pp, 32K)—Compliance of non-study generated data

GLP Regulations Advisory No. 14 (PDF) (3 pp, 41K)—Compliance of confirmatory method trials

GLP Regulations Advisory No. 18 (PDF) (3 pp, 40K)—Study protocol, number per study

GLP Regulations Advisory No. 19 (PDF) (2 pp, 39K)—General questions on GLP interpretation

GLP Regulations Advisory No. 28 (PDF) (3 pp, 34K)—Efficacy studies compliance

GLP Regulations Advisory No. 29 (PDF) (3 pp, 34K)—Exploratory studies compliance

GLP Regulations Advisory No. 30 (PDF) (3 pp, 34K)—Analysis of test substance mixture

GLP Regulations Advisory No. 32 (PDF) (4 pp, 30K)—Analysis of test substance mixture

GLP Regulations Advisory No. 33 (PDF) (3 pp, 27K)—Method revaluation compliance

GLP Regulations Advisory No. 39 (PDF) (3 pp, 25K)—Generic protocol

GLP Regulations Advisory No. 43 (PDF) (3 pp, 34K)—One trial one location

GLP Regulations Advisory No. 45 (PDF) (3 pp, 34K)—Test substance definition

GLP Regulations Advisory No. 46 (PDF) (3 pp, 35K)—Test facility description

GLP Regulations Advisory No. 47 (PDF) (2 pp, 32K)—Self-carbonized copies for exact copies

GLP Regulations Advisory No. 49 (PDF) (4 pp, 37K)—Multi-testing reporting requirements

GLP Regulations Advisory No. 53 (PDF) (2 pp, 24K)—Signature and date thereof on final report

GLP Regulations Advisory No. 55 (PDF) (3 pp, 27K)—Test, control and reference substance characterization

GLP Regulations Advisory No. 58 (PDF) (3 pp, 26K)—FIFRA GLPS Compliance by Interregional Research Project No. 4

GLP Regulations Advisory No. 64 (PDF) (3 pp, 27K)—Performance of characterization as separates or parts of

GLP Regulations Advisory No. 65 (PDF) (3 pp, 27K)—Characterization of test substances and mixtures

GLP Regulations Advisory No. 70 (PDF) (3 pp, 27K)—Final reporting of tests ruled invalid 

GLP Regulations Advisory No. 72 (PDF) (3 pp, 25K)—Use of management as technicians in studies by small companies

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Quality Assurance

GLP Regulations Advisory No. 03 (PDF) (3 pp, 33K)—Frequency of Quality Assurance Inspections

GLP Regulations Advisory No. 13 (PDF) (3 pp, 41K)—Frequency of Quality Assurance audits at multiple test sites

GLP Regulations Advisory No. 34 (PDF) (3 pp, 37K)—Number of compliance statements and Quality Assurance reports

GLP Regulations Advisory No. 48 (PDF) (2 pp, 32K)—Quality Assurance Unit's responsibilities

GLP Regulations Advisory No. 52 (PDF) (3 pp, 28K)—Quality Assurance Unit function

GLP Regulations Advisory No. 66 (PDF) (3 pp, 26K)—Clarification of Advisories 52 and 59

GLP Regulations Advisory No. 68 (PDF) (3 pp, 25K)—Clarification of reporting protocols by QAU inspections

GLP Regulations Advisory No. 79 (PDF) (2 pp, 21K)—GLPS compliance statement for interim reports (40 CFR sec. 160.12)

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Retention

GLP Regulations Advisory No. 02 (PDF) (3 pp, 35K)—Samples, retention times and schedules

GLP Regulations Advisory No. 07 (PDF) (2 pp, 32K)—Retention of soil samples

GLP Regulations Advisory No. 09 (PDF) (4 pp, 37K)—Retention time for wet specimens, Number of signatures on compliance statement and Test substance metabolites listed in protocol

GLP Regulations Advisory No. 16 (PDF) (2 pp, 31K)—Retention of reserve test substance samples

GLP Regulations Advisory No. 36 (PDF) (61 pp, 251K)— Retention time of wet specimens

GLP Regulations Advisory No. 50 (PDF) (3 pp, 35K)—Test sample substance retention

GLP Regulations Advisory No. 57 (PDF) (3 pp, 26K)—Raw old study data retention for new study

GLP Regulations Advisory No. 60 (PDF) (4 pp, 29K)—Retention of original storage containers

GLP Regulations Advisory No. 62 (PDF) (3 pp, 26K)—Test substance container retention and surplus substance use

GLP Regulations Advisory No. 76 (PDF) (3 pp, 24K)—Raw data retention periods for TSCA/GLPs

GLP Regulations Advisory No. 83 (PDF) (3 pp, 24K)—Retention of raw data in support of pesticide registration

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Storage

GLP Regulations Advisory No. 05 (PDF) (4 pp, 37K)—Container storage maintenance

GLP Regulations Advisory No. 21 (PDF) (3 pp, 34K)—Storage of test substance mixed with carrier

GLP Regulations Advisory No. 23 (PDF) (3 pp, 33K)—Test substance storage stability

GLP Regulations Advisory No. 24 (PDF) (4 pp, 38K)—Test substance container storage

GLP Regulations Advisory No. 25 (PDF) (4 pp, 38K)—Test substance container storage

GLP Regulations Advisory No. 26 (PDF) (4 pp, 38K)—Test substance container storage

GLP Regulations Advisory No. 27 (PDF) (3 pp, 34K)—Test substance container storage

GLP Regulations Advisory No. 37 (PDF) (3 pp, 24K)—Maintenance of test substance container storage

GLP Regulations Advisory No. 40 (PDF) (4 pp, 28K)—Test substance container storage

GLP Regulations Advisory No. 41 (PDF) (4 pp, 37K)—Test substance container storage

GLP Regulations Advisory No. 51 (PDF) (3 pp, 27K)—Test substance container storage

GLP Regulations Advisory No. 56 (PDF) (4 pp, 29K)—Test material storage requirements

GLP Regulations Advisory No. 63 (PDF) (4 pp, 29K)—Disposition of used test substance containers

GLP Regulations Advisory No. 67 (PDF) (4 pp, 29K)—Test substance storage containers

GLP Regulations Advisory No. 74 (PDF) (5 pp, 31K)—Retention of empty storage containers - excessive numbers thereof

GLP Regulations Advisory No. 77 (PDF) (2 pp, 21K)—Storage stability studies (40 CFR sec. 160.135(a) and 40 CFR sec. 160.135(b))

GLP Regulations Advisory No. 78 (PDF) (4 pp, 28K)—Retention of test substance containers (40 CFR sec. 160.105(c))

GLP Regulations Advisory No. 81 (PDF) (4 pp, 28K)—est substance storage containers 40 CFR sec. 160.105(c) exception

GLP Regulations Advisory No. 82 (PDF) (4 pp, 43K)—Retention and retaining reserve samples from each batch of test substance (40 CFR sec. 160.195)

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Study Archive

GLP Regulations Advisory No. 12 (PDF) (3 pp, 41K)—Off-site archives

GLP Regulations Advisory No. 31 (PDF) (3 pp, 35K)—Archive of records-time/location/duration of study

GLP Regulations Advisory No. 38 (PDF) (2 pp, 23K)—Responsibility of archive

GLP Regulations Advisory No. 42 (PDF) (5 pp, 39K)—Archiving requirements—number of reports/protocols, Reference and control substances characterization

GLP Regulations Advisory No. 44 (PDF) (3 pp, 34K)—Archiving of raw data

GLP Regulations Advisory No. 54 (PDF) (2 pp, 24K)—Archiving requirements

GLP Regulations Advisory No. 61 (PDF) (3 pp, 27K)—Archiving wet samples for extended periods

GLP Regulations Advisory No. 75 (PDF) (2 pp, 23K)—Archive of records of out of business companies

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Study Director

GLP Regulations Advisory No. 04 (PDF) (3 pp, 35K)—Study Director/Test Facility, number per study

GLP Regulations Advisory No. 06 (PDF) (4 pp, 37K)—Study Director number per study

GLP Regulations Advisory No. 08 (PDF) (3 pp, 36K)—Study Director number per study

GLP Regulations Advisory No. 15 (PDF) (3 pp, 34K)—Off site location of study director/QA

GLP Regulations Advisory No. 17 (PDF) (3 pp, 40K)—Off site location of study director/QA

GLP Regulations Advisory No. 20 (PDF) (3 pp, 41K)—Number of study directors per study

GLP Regulations Advisory No. 22 (PDF) (3 pp, 34K)— - Study director number per study

GLP Regulations Advisory No. 59 (PDF) (4 pp, 29K)—CEO/President serving as Study Director

GLP Regulations Advisory No. 73 (PDF) (3 pp, 26K)—GLP requirement to assign a study director

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