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 sample analysis and method validation to deliver the highest level of quality assurance and data integrity. The bioanalytical laboratory holds both formal GLP and ISO 17025 accreditation and certificates can be provided on request.
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 2001, Section VI, Application of Validated Method to Routine Drug Analysis. To ensure we keep up with the most recent US regulatory issues and interpretations in bioanalysis we regularly send our senior analytical chemists to appropriate US based training and workshops. In addition our senior bioanalytical QA associate is a registered quality assurance professional in GLPs with the US based SQA (Society of Quality Assurance).
21 CFR Part 11 – Compliant Software Systems
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