The CSU Quality Program assists in designing, developing, and overseeing quality systems as needed at the individual laboratory or program level. As part of oversight activities, the Quality Program can provide the services of a full-service Quality Assurance Unit, assisting in protocol development, inspections of the facility, study critical phases, study records and study reports, gap analysis, training, classroom guest lectures on Quality in Science, SOP development, method validation, etc.
QA Services Offers Training in the Following Areas:
- Good Clinical Practices (GCP)
- Good Clinical Laboratory Practices (GCLP)
- Good Documentation Practices (GDP)
- Good Laboratory Practices (GLP)
- Method Validation
- SOP Development
- Protocol Development
- Quality in Science Overview
Good Clinical Practices (GCP)
The Good Clinical Practices are an international quality standard that describes the conditions and processes under which research using clinical subjects (both human and animal) is conducted and that define the roles and responsibilities of clinical trial sponsors, investigators, and monitors.
Additional guidance is also available for laboratories that conduct laboratory analysis in support of a clinical trial, which are known as the Good Clinical Laboratory Practices (GCLP).
Good Clinical Laboratory Practices (GCLP)
The GCLPs are an international quality system for laboratories that undertake the analysis of samples from clinical trials using Good Laboratory Practice standards, while assuring Good Clinical Practice standards are met
Good Documentation Practices (GDP)
The GDPs are an internationally accepted practice by which research and manufacturing data are documented and preserved. While some details of the GDPs are codified (e.g., GLP study conduct requirements), there is no single law that describes the standards that the current research community expects as part of sound research practices.
Good Laboratory Practice (GLP)
In the US, the GLPs are regulated quality standards that are designed to ensure the quality, integrity, and reliability of non-clinical test data submitted to federal agencies in support of a research or marketing permit under federal law. GLPs encompass both lab and field research and dictate the organization, process, and conditions under which studies are planned, performed, monitored, recorded, and reported.
Method Validation
The objective of method validation is to demonstrate that the procedures you use are suitable for their intended purpose. Selective and sensitive methods for the quantitative evaluation of drugs and their metabolites are critical for the successful conduct of preclinical and/or biopharmaceutics and clinical pharmacology studies; therefore, having confidence in method results is essential in safety research as well as many other research outlets. Method validation includes systematically assessing the procedures to demonstrate that a particular method used for quantitative measurement of analytes in a given biological matrix, such as blood, plasma, serum, or urine, is reliable and reproducible for the intended use.