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Good Laboratory Practices: Questions and Answers - Test Control and Reference Substance Characterization
FIFRA Topics
- Good Laboratory Practices
- FIFRA Grants
- Inspections
- Worker Protection Safety
- Pesticide Producing Establishments
- Pesticide Imports and Exports
EPA has prepared responses to several questions in order to help clarify the Good Laboratory Practices Standards (GLPS) rule. The Questions and Answers are grouped into eleven different categories listed below. The following Questions and Answers serve as official written policy.
Applicability
Definitions
Study Director
Quality Assurance Unit (QAU)
Facilities
Test Control and Reference Substance Characterization
- Do characterization requirements at 40 CFR 160.105 apply to analytical standards?
- Can data developed by the supplier of the standard be accepted? If not, can it be used on an "interim" basis until the standard is adequate characterized?
- What documentation would apply to standards?
Test Substance Storage Containers
Protocols
Reporting
Archives
GLP Violations
1. Do characterization requirements at 40 CFR 160.105 apply to analytical standards?
Analytical standards are considered to be reference substances and are subject to all GLP standards that apply to reference substances, including characterization.
2. Can data developed by the supplier of the standard be accepted? If not, can it be used on an "interim" basis until the standard is adequate characterized?
Information developed by a supplier can be used to support characterization requirements, but the compliance statement for the overall study must state whether such data were developed under GLPS. Any data not developed under GLPS may be rejected by the Agency. Analyses must be performed to characterize the reference substance before it is used. In the case that a standard is used before it is analyzed, this is a violation of 40 CFR 160.105(a), which requires such determinations to be made before the standard is used in the study.
3. What documentation would apply to standards?
Full characterization information as stated at 40 CFR 160.105 is required of standards. This section requires that any information that is appropriate for defining the standard, including identity, strength, purity, or composition, shall be determined for each batch before it is used. In the case of an analytical standard, for example, it is necessary to obtain analysis data documenting the identity, strength, and purity, for each batch. A labeled assay value, in and of itself, is insufficient.