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Good Laboratory Practices - Advisories
FIFRA Topics
- Good Laboratory Practices
- FIFRA Grants
- Inspections
- Worker Protection Safety
- Pesticide Producing Establishments
- Pesticide Imports and Exports
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 the Agriculture Division of the Office of Compliance. This interpretation is official policy in the GLP program and should be followed by all GLP inspectors.
Advisory Topics
Compliance Monitoring
GLP
Regulations Advisory No. 01 (PDF) (4pp,
37K)
- Solubility studies
GLP
Regulations Advisory No. 10 (PDF) (3pp, 33K
- Compliance of test substance
GLP
Regulations Advisory No. 11 (PDF) (2pp, 32K)
- Compliance of non-study generated data
GLP
Regulations Advisory No. 14 (PDF) (3pp, 41K)
- Compliance of confirmatory method trials
GLP
Regulations Advisory No. 18 (PDF) (3pp, 40K)
- Study protocol, number per study
GLP
Regulations Advisory No. 19 (PDF) (2pp, 39K)
- General questions on GLP interpretation
GLP
Regulations Advisory No. 28 (PDF) (3pp, 34K)
- Efficacy studies compliance
GLP
Regulations Advisory No. 29 (PDF) (3pp, 34K)
- Exploratory studies compliance
GLP
Regulations Advisory No. 30 (PDF) (3pp, 34K)
- Analysis of test substance mixture
GLP
Regulations Advisory No. 32 (PDF) (4pp, 30K)
- Analysis of test substance mixture
GLP
Regulations Advisory No. 33 (PDF) (3pp, 27K)
- Method revaluation compliance
GLP
Regulations Advisory No. 39 (PDF) (3pp, 25K)
- Generic protocol
GLP
Regulations Advisory No. 43 (PDF) (3pp, 34K)
- One trial one location
GLP Regulations Advisory No. 45 (PDF) (3pp,
34K)
- Test substance definition
GLP
Regulations Advisory No. 46 (PDF) (3pp, 35K)
- Test facility description
GLP
Regulations Advisory No. 47 (PDF) (2pp, 32K)
- Self-carbonized copies for exact copies
GLP
Regulations Advisory No. 49 (PDF) (4pp, 37K)
- Multi-testing reporting requirements
GLP
Regulations Advisory No. 53 (PDF) (2pp, 24K)
- Signature and date thereof on final report
GLP
Regulations Advisory No. 55 (PDF) (3pp, 27K)
- Test, control and reference substance characterization
GLP
Regulations Advisory No. 58 (PDF) (3pp, 26K)
- FIFRA GLPS Compliance by Interregional Research Project No. 4
GLP
Regulations Advisory No. 64 (PDF) (3pp, 27K)
- Performance of characterization as separates or parts of
GLP
Regulations Advisory No. 65 (PDF) (3pp, 27K)
- Characterization of test substances and mixtures
GLP
Regulations Advisory No. 70 (PDF) (3pp, 27K)
- Final reporting of tests ruled invalid
GLP
Regulations Advisory No. 72 (PDF) (3pp, 25K)
- Use of management as technicians in studies by small companies
Quality Assurance
GLP
Regulations Advisory No. 03 (PDF) (3pp, 33K)
- Frequency of Quality Assurance Inspections
GLP
Regulations Advisory No. 13 (PDF) (3pp, 41K)
- Frequency of Quality Assurance audits at multiple test sites
GLP
Regulations Advisory No. 34 (PDF) (3pp, 37K)
- Number of compliance statements and Quality Assurance reports
GLP
Regulations Advisory No. 48 (PDF) (2pp, 32K)
- Quality Assurance Unit's responsibilities
GLP
Regulations Advisory No. 52 (PDF) (3pp, 28K)
- Quality Assurance Unit function
GLP
Regulations Advisory No. 66 (PDF) (3pp, 26K)
- Clarification of Advisories 52 and 59
GLP
Regulations Advisory No. 68 (PDF) (3pp, 25K)
- Clarification of reporting protocols by QAU inspections
GLP
Regulations Advisory No. 79 (PDF) (2pp, 21K)
- GLPS compliance statement for interim reports (40 CFR 160.12)
Retention
GLP
Regulations Advisory No. 02 (PDF) (3pp, 35K)
- Samples, retention times, schedules
GLP
Regulations Advisory No. 07 (PDF) (2pp, 32K)
- Retention of soil samples
GLP
Regulations Advisory No. 09 (PDF) (4pp, 37K)
- Retention time for wet specimens, Number of signatures on compliance statement, Test substance metabolites listed in protocol
GLP
Regulations Advisory No. 16 (PDF) (2pp, 31K)
- Retention of reserve test substance samples
GLP
Regulations Advisory No. 35 (PDF) (3pp, 27K)
- Retention of raw data
GLP
Regulations Advisory No. 36 (PDF) (61pp, 251K)
- Retention time of wet specimens
GLP
Regulations Advisory No. 50 (PDF) (3pp, 35K)
- Test sample substance retention
GLP
Regulations Advisory No. 57 (PDF) (3pp, 26K)
- Raw old study data retention for new study
GLP
Regulations Advisory No. 60 (PDF) (4pp, 29K)
- Retention of original storage containers
GLP
Regulations Advisory No. 62 (PDF) (3pp, 26K)
- Test substance container retention and surplus substance use
GLP
Regulations Advisory No. 76 (PDF) (3pp, 24K)
- Raw data retention periods for TSCA/GLPs
Storage
GLP
Regulations Advisory No. 05 (PDF) (4pp, 37K)
- Container storage maintenance
GLP
Regulations Advisory No. 21 (PDF) (3pp, 34K)
- Storage of test substance mixed with carrier
GLP
Regulations Advisory No. 23 (PDF) (3pp, 33K)
- Test substance storage stability
GLP
Regulations Advisory No. 24 (PDF) (4pp, 38K)
- Test substance container storage
GLP
Regulations Advisory No. 25 (PDF) (4pp, 38K)
- Test substance container storage
GLP
Regulations Advisory No. 26 (PDF) (4pp, 38K)
- Test substance container storage
GLP
Regulations Advisory No. 27 (PDF) (3pp, 34K)
- Test substance container storage
GLP
Regulations Advisory No. 37 (PDF) (3pp, 24K)
- Maintenance of test substance container storage
GLP
Regulations Advisory No. 40 (PDF) (4pp, 28K)
- Test substance container storage
GLP
Regulations Advisory No. 41 (PDF) (4pp, 37K)
- Test substance container storage
GLP
Regulations Advisory No. 51 (PDF) (3pp, 27K)
- Test substance container storage
GLP
Regulations Advisory No. 56 (PDF) (4pp, 29K)
- Test material storage requirements
GLP
Regulations Advisory No. 63 (PDF) (4pp, 29K)
- Disposition of used test substance containers
GLP
Regulations Advisory No. 67 (PDF) (4pp, 29K)
- Test substance storage containers
GLP
Regulations Advisory No. 74 (PDF) (5pp, 31K)
- Retention of empty storage containers - excessive numbers thereof
GLP
Regulations Advisory No. 77 (PDF) (2pp, 21K)
- Storage stability studies (40 CFR 160.135 (a) and 40 CFR 160.135 (b))
GLP
Regulations Advisory No. 78 (PDF) (4pp, 28K)
- Retention of test substance containers (40 CFR 160.105 (c))
GLP
Regulations Advisory No. 81 (PDF) (4pp, 28K)
- Test substance storage containers 40 CFR 160.105 (c) exception
GLP
Regulations Advisory No. 82 (PDF) (4pp, 43K)
- Retention and retaining reserve samples from each batch of test substance
(40 CFR 160.195)
Study Archive
GLP
Regulations Advisory No. 12 (PDF) (3pp, 41K)
- Off-site archives
GLP
Regulations Advisory No. 31 (PDF) (3pp, 35K)
- Archive of records-time/location/duration of study
GLP
Regulations Advisory No. 38 (PDF) (2pp, 23K)
- Responsibility of archive
GLP
Regulations Advisory No. 42 (PDF) (5pp, 39K)
- Archiving requirements - number of reports/protocols, Reference and control substances characterization
GLP
Regulations Advisory No. 44 (PDF) (3pp, 34K)
- Archiving of raw data
GLP
Regulations Advisory No. 54 (PDF) (2pp, 24K)
- Archiving requirements
GLP
Regulations Advisory No. 61 (PDF) (3pp, 27K)
- Archiving wet samples for extended periods
GLP
Regulations Advisory No. 75 (PDF) (2pp, 23K)
- Archive of records of out of business companies
Study Director
GLP
Regulations Advisory No. 04 (PDF) (3pp, 35K)
- Study Director/Test Facility, number per study
GLP
Regulations Advisory No. 06 (PDF) (4pp, 37K)
- Study Director number per study
GLP
Regulations Advisory No. 08 (PDF) (3pp, 36K)
- Study Director number per study
GLP
Regulations Advisory No. 15 (PDF) (3pp, 34K)
- Off site location of study director/QA
GLP
Regulations Advisory No. 17 (PDF) (3pp, 40K)
- Off site location of study director/QA
GLP
Regulations Advisory No. 20 (PDF) (3pp, 41K)
- Number of study directors per study
GLP
Regulations Advisory No. 22 (PDF) (3pp, 34K)
- Study director number per study
GLP
Regulations Advisory No. 59 (PDF) (4pp, 29K)
- CEO/President serving as Study Director
GLP
Regulations Advisory No. 73 (PDF) (3pp, 26K)
- GLP requirement to assign a study director