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Good Laboratory Practices: Questions and Answers - Facilities

FIFRA Topics

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
  1. Is it permissible to store mixed feeds containing the test substance in the same room with the test system during feeding studies?
Test Control and Reference Substance Characterization
Test Substance Storage Containers
Protocols
Reporting
Archives
GLP Violations

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1. Is it permissible to store mixed feeds containing the test substance in the same room with the test system during feeding studies?

As discussed at 40 CFR 160.47(b) test substance mixture storage areas must be separate from the areas where test systems are kept. However, working quantities of test substance mixtures need not be stored in separate rooms from test systems. Separate areas within the same room may be designated for test substance mixture storage and test systems as long as the separation is adequate to preserve the integrity of the study and the identity, strength, purity and stability of the mixture.

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Compliance Assistance | Compliance Monitoring | Compliance Incentives

 


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