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# FDA Proposing GLP Quality System
- URL: https://www.fdaweb.com/fda-proposing-glp-quality-system/
- Published: 2016-08-23T12:00:00.000Z
- Updated: 2026-09-14T21:26:20.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5136582

FDA is proposing to amend the good laboratory practice (GLP) regulations for non-clinical laboratory studies to require a GLP Quality System approach when safety and toxicity studies support or are intended to support applications or submissions for FDA regulated products. A *Federal Register* [notice](https://s3.amazonaws.com/public-inspection.federalregister.gov/2016-19875.pdf?ref=fdaweb.com) says the agency also is proposing additional management responsibilities and standard operating procedures (SOPs) consistent with the proposed GLP quality system. And it proposes to revise the testing facility definition to reflect current practices for conducting non-clinical laboratory studies, and particularly multi-site studies. Comments on the proposal are due within 90 days of the anticipated 8/24 publication of the notice.

The notice says that current regulations include many aspects of a quality system approach, but certain fundamentals of a fully implemented GLP quality system considered essential to a quality system, such as certain SOPs and adequate management roles, responsibilities, and accountability, are not presently required.

“The GLP Quality System will provide additional responsibilities for testing facility management and new responsibilities for maintaining SOPs,” FDA says. “We propose modifications to the definition of a testing facility to be applicable to all nonclinical laboratory studies, whether they are conducted at a single facility or at multiple sites. We propose amending roles and functions consistent with the revised testing facility definition. FDA expects that a GLP quality system will provide the appropriate framework for building quality into a non-clinical laboratory study and will result in more reliable data for FDA to consider when making regulatory decisions.”

The notice says that in addition to wanting to improve the quality and integrity of study data, the agency is modernizing the existing regulations to further its efforts to encourage implementation of principles of the “3Rs” — to reduce, refine, and replace animal use in testing. “This approach seeks to minimize the use of animals in such testing and promote more humane, appropriate, and specific test methods for evaluating product safety,” it says.