The FDA designed the GLP regulations to ensure the validity, integrity and reliability of nonclinical, safety data submitted for FDA evaluation and approval. Metabolic Solutions offers GLP compliant analyses, Part 11 compliant data handling and delivery as well as GLP sample/data archiving as part of our comprehensive isotope testing services. Unique is our ability to perform stable isotope analysis under GLP regulations. Annual training assures every member of the Metabolic Solutions staff is equipped to properly carry out these GLP procedures.
Upon receipt of samples, laboratory personnel will receive, inspect and log those samples into our validated sample management database. Each sample will be automatically assigned a unique number and labels will be generated to identify each sample. Any problems or discrepancies with the samples will be immediately documented and the client contacted by the Study Director. All pertinent information concerning that sample such as client name, sample name and/or ID#, collection date and time point are entered and permanently associated with the MSI sample number in the validated sample management database.
Our laboratory offers method validation services for analytical procedures not currently offered under GLP. See a list of our current Validated GLP Assays at Metabolic Solutions here.
Each validated assay has specific standards and controls as well as other system suitability checks to assure that every stable isotope analytical run is acceptable. These assays have been verified for:
Finally, standard operating procedures (SOP) are established to ensure adherence to the validated method.
When the analyst is satisfied that the results of the assay are acceptable, the data is entered into a validated Part 11 compliant spreadsheet and appropriate calculations, as specified in the individual methods, are applied.
The raw data, final data and calculations are forwarded along with the original investigator paperwork and receiving documents to the Director of Quality Assurance for final analytical review. Each sample is checked for its identifier, each process is checked with regard to standard, control and other system suitability parameters according to the SOPs. Finally, each data point is checked for entry accuracy.
The data is next forwarded to the Study Director for final review of the stable isotope analysis data and transmittance to the client. Metabolic Solutions can deliver the data in a number of formats directly to the end user of the data across secure web portals.
Samples are kept in a specified GLP freezer that is temperature monitored 24/7 and protected with a back up generator. The data becomes part of the Metabolic Solutions secure database and the raw data (paper) is locked in a secure facility in a waterproof container. The length of time and any other particular conditions for archiving of samples or data can be agreed upon at the time of the study.