Regulated Bioanalysis

To smooth the way for regulatory acceptance and improve chances of a successful submission, QPS complies with FDA’s GLP regulations and guidance documents, as well as incorporates ex-USA GLP principles and regulations. Once the quality of the methods, data and results has been verified, a Quality Assurance Statement will be included in the final report. For regulated bioanalysis, QPS validates robust assays in accordance with:

• The Food and Drug Administration (FDA) Good Laboratory Practice (GLP) regulations as set forth in Title 21 of the U.S. Code of Federal Regulations Part 58

• The Organization for Economic Co-operation and Development (OECD) Principles of Good Laboratory Practice [C (97) 186/Final]

• The Japanese Ministry of Health, Labor and Welfare (MHLW) No. 21, March 26, 1997

• The “FDA Guidance for Industry for Bioanalytical Method Validation,” May 2001

• Workshop report, “Quantitative Bioanalytical Method Validation and Implementation: Best Practices for Chromatographic and Ligand Binding Assays,” February 2007

• Workshop report, “AAPS Workshop on Current Topics in GLP Bioanalysis: Assay Reproducibility for Incurred Samples - Implications of Crystal City Recommendations,” April 2009