GLP Analysis

Protein analysis performed in compliance with GLP

Protein Contract Analyses can be performed in compliance with the OECD principles of Good Laboratory Practise (GLP) at Alphalyse.

Study Protocol

A Study Protocol is written as an agreement between the Sponsor and Alphalyse describing where, when and how the analysis will be performed. The Study Protocol contains the experimental design, standard operating procedures (SOPs) and analytical methods to be used, a description of the test items to be analysed, and which results should be recorded, reported and archived.

Study Director/Principle Investigator

A Study Director is appointed, or a Principle Investigator if the analysis is part of a multisite GLP study. The Study Director has the overall responsibility for the conduct, analysis, interpretation, documentation and reporting of the GLP study results.

Study Report/Analysis Certificate

A Study Report is written with the analysis results and eventual deviations.  The Study Report is signed by the Study Director for compliance with GLP, and by the Sponsor upon completion of the study. For specific analyses, an Analysis Certificate can be issued with the analysis results.

Quality Assurance

The Quality Assurance (QA) unit performs the internal control of each study. QA has the responsibility to assure that the facility, personnel, SOPs, records, final reports, and archives are in conformance with GLP regulations. QA signs the final Study Report.