The CSU Quality Program offers assistance in the design, development and oversight of 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, providing assistance in protocol development, inspections of 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 Laboratory Practices
- Good Clinical Practices (GCP) and Good Clinical Laboratory Practices (GCLP)
- Good Documentation Practices (GDP) and the development of good record systems
- SOP Development
- Protocol Development
- Method Validation
- Quality in Science Overview
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 conducted laboratory analysis in support of a clinical trial which are known as the Good Clinical Laboratory Practices (GCLP). Links can be found on the GCLP page.
The GCLPs are an international quality system for laboratories which undertake the analysis of samples from clinical trials using Good Laboratory Practice standards while assuring Good Clinical Practice standards are met.
The GDPs are an internationally accepted practice by which research and manufacturing data is 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.
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.
The objective of method validation is to demonstrate that 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 are 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.