Proposed GLP Quality System vs. Current GLP Regulations
The Food and Drug Administration (FDA) on August 24, 2016, published a proposed rule which would amend regulations. These rules govern good laboratory practices (GLPs) for nonclinical laboratory studies to require a fully integrated quality systems approach, referred to as a “GLP Quality System.”
The proposed changes by the FDA include increased focus on quality and integrity of data essential to assess the safety and effectiveness of FDA-regulated products and incorporates data quality principles with OECD principles. In addition, the proposed changes would introduce and modify industry definitions, terms, and organizational and personnel roles and responsibilities.
NOTE: The proposed regulations are not finalized and can currently review proposed changes and submit to the FDA any questions you have before November 22, 2016. To learn more about the specifics of the on submitting comment you can click here.
If you have questions or concerns on how this may impact your business, please feel free to contact QACompliant at: GLP@QACompliant.com