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Good Laboratory Practices: Questions and Answers - Quality Assurance Unit
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)
- Is it acceptable to inspect study-related procedures at a time other than when the study is ongoing?
- What would constitute adequate inspection of the ongoing study? Would an audit of the protocol or of data records be adequate?
Facilities
Test Control and Reference Substance Characterization
Test Substance Storage Containers
Protocols
Reporting
Archives
GLP Violations
1. Is it acceptable to inspect study-related procedures at a time other than when the study is ongoing?
The GLPS state at 40 CFR 160.35(a) that a testing facility shall have a Quality Assurance Unit (QAU) that shall monitor each study to assure management that the facilities, equipment, personnel, methods, practices, records, and controls are in conformance with the GLPS. The GLPS further state at 40 CFR 160.35(b)(3) that the QAU shall inspect each study at intervals adequate to ensure the integrity of the study.
Clearly, the QAU must conduct inspections adequate to provide the assurances required at 40 CFR 160.35(a) and, in the course of so doing, must inspect each study at least once. All parameters must be verified adequate for each site, but it is acceptable to use inspections conducted during other studies to provide necessary assurances. It is also acceptable to use inspections conducted when no study is in progress to assure that methods, personnel, etc. at a particular site are in conformance with GLPS. However, acceptability of such inspections is contingent on assuring that the facilities, personnel, methods, etc., which are inspected are representative of those used in the study. Note that it is necessary to reinspect facilities periodically to account for changes in personnel, equipment etc. Finally, no matter how complete QAU inspectional coverage is regarding the sites involved in a study, it is still necessary to conduct at least one inspection of study activities while the study is in progress.
2. What would constitute adequate inspection of the ongoing study? Would an audit of the protocol or of data records be adequate?
At least one inspection must be conducted while the study is in progress. Under GLPS, the QAU monitoring of protocols, data records, or other documentation phases of a study are important just as is directly observing the experimental phase of the study. However, the GLPS state at 40 CFR 160.35(b)(3) that inspections must be done at intervals adequate to ensure the integrity of the study, and further, at 40 CFR 160.35(b)(4), that periodic status reports noting problems and corrective actions be submitted to management.
An audit of a study protocol would be of very limited utility since the subsequent reporting would be to management which, in all likelihood, has already reviewed the protocol. Data record audits would also be of very limited utility since they may occur after all experimental work is completed--in short, too late for any corrective actions to be taken. This problem also applies to protocol audits conducted after the experimental phase is completed. Thus, reliance solely on such types of audits would not meet the GLP requirements as stated at 40 CFR 160.35.