Our Commitment to Quality
- All work is performed in accordance with our Standard Operating Procedures or if an SOP is not available, we follow detailed procedures.
- Our analysts have been trained on the GLP and GMP regulations, and are proficient in each assay that they perform.
- Each SOP has appropriate Worksheets which are used by the analyst to record lot numbers of reagents and columns, any calculations required for the analysis and other relevant information.
- Worksheets are signed by the Analyst and by a second scientist who has reviewed the information on the Worksheet.
- We include the appropriate standards for comparing the performance of our analysis run-to-run and to assess the chromatographic separation from run-to-run.
- All GLP and GMP testing is performed following a Study Protocol which has been prepared by GlycoSolutions Corporation.
- Any deviation(s) from the Study Protocol or SOP is documented and any necessary corrective action is taken prior to continuing the study.
- GlycoSolutions QA performs a 100% audit on all GLP or GMP studies and issues a Quality Assurance Statement or Certificate of Analysis prior to the report being finalized.
- After completing the study, GlycoSolutions prepares a Final Report containing the results and all necessary information about the study.
- Copies of the report and QA statement, or a Certificate of Analysis are sent to the client at the completion of the study. Copies of the entire study packet can be provided at the request of the client.
