Quality Assurance

Our Quality Assurance ensures that BA/BE study is performed in compliance with the general regulatory requirements and international standards for BA/BE study that covers the clinical and analytical aspect.

QA must review all phases of the studies, from planning, through inspecting of ongoing studies, to reporting and archiving of documentation to be effective, QAU has access to staff documents and procedures at all levels of organization, and be supported by top management.

QA in Clinical Aspect

Our SOPs that related to the clinical activity comply with the Good Clinical Practice (GCP), an international standard for clinical trial.

QA in Analytical Aspect

To perform the reliable result in BA/BE Study, the bioanalytical techniques conducted in GRC are accredited with ISO/IEC 17025:2005 and apply Good Laboratory Practice (GLP) requirements. As a reference and general recommendations in developing bioanalytical method validation and procedure, GRC adopts the “Guidance for Industry Bioanalytical Method Validation” from US FDA and EMEA.

Our own SOPs ensures that our procedures, systems, and associated documentation and controls comply with regulatory GCP and GLP guidelines and industry standards.
Our QA role extends beyond auditing to provide education and training of the GRC staff.