QUALITY ASSURANCE DEPARTMENT

The Novagenix Bioanalytical Pharmaceutical R&D Center quality assurance system has been implemented since 2000 and is continuously improved in accordance with GLP, GCP, ISO 9001 and ISO 17025 regulations and standards. For our current certificates, please click here.

Quality assurance provides the following services:

• Plans, conducts and reports inspections with the quality assurance program.
• Prepares annual training plans, organizes personnel training.
• Manages SOP and quality system documentation.
• Follows up to date of ICH, EMA, FDA and national guidelines and regulations.
• Provides necessary documentation and information in sponsor and legal authority audits.
• Applies risk-based approach in quality management system and projects.
• Ensures the validity and accuracy of the study results.
• Performs system audit in line with the annual internal audit plan.
• Conducts project audits in line with the master plan.
• Clinical center controls according to GCP.
• Prepares audit reports and initiates necessary corrective actions.
• Evaluates and follows up corrective actions.