Quality Assurance
Quality assurance is performed in accordance with CPR SOPs and OECD and FDA GLP guidances. Apart from Non-Clinical GLP studies, GLP processes are also applied to clinical trial samples to deliver the highest level of quality assurance and data integrity.
Criteria for acceptability of an assay are stringently adhered to in accordance with CPR's SOPs and the FDA's Guidance for Industry for Bioanalytical Method Validation, Section VI, Application of Validated Method to Routine Drug Analysis.
21 CFR Part 58 Good Laboratory Practices: Guidance for Industry Bioanalytical Method Validation, click below:
http://www.fda.gov/cder/guidance/4252fnl.pdf
21 CFR Part 11-Compliant Software Systems
Criteria for acceptability of an assay are stringently adhered to in accordance with CPR's SOPs and the FDA's Guidance for Industry for Bioanalytical Method Validation, Section VI, Application of Validated Method to Routine Drug Analysis.
21 CFR Part 58 Good Laboratory Practices: Guidance for Industry Bioanalytical Method Validation, click below:
http://www.fda.gov/cder/guidance/4252fnl.pdf
21 CFR Part 11-Compliant Software Systems
- PE Sciex Analyst® v 1.4.2
- Shimadzu CLASS VP 7 software