Quality Assurance Services

 

ACDIMA BioCenter Quality Assurance unit comprises of high qualified team to ensure the compliance of the whole procedures with the international regulations and guidelines. Our quality systems are established to maintaining a standard of excellence and an optimum performance by the implementation of high standard quality procedures and best practices.

 

The quality assurance department assures the adherence of conducted bioequivalence study-related procedures to GCP, GLP, (International Conference on Harmonisation) ICH-GCP, and in-house SOPs. Furthermore, identifying critical control points, establishing preventive measures, and corrective actions.

The quality assurance mission is providing a trusted, reliable service that is driven by a firmed system that follows the updated international regulations and quality standards. Therefore, satisfy sponsors' expectations and customer requirements. Additionally, ACDIMA BioCenter quality assurance unit aims for continuous improvement and periodic checks to ensure the procedures and operations are up to date with the guidelines.  

Quality assurance personnel has different scientific backgrounds with the required knowledge needed to corporate with other departments.

Quality assurance unit services include but not limited to: 

  • External and internal audits related to Good Clinical Practices and Good Laboratories Practices, reviewing source documentation, procedures, raw data, and reports.

  • Auditing Dispensing procedure and check handling of IMP.

  • Auditing study protocol, bioanalytical report, validation report, integrated study report, and abbreviated report.

  • Auditing raw data, source documents, and reports of bioanalytical method validation, routine analysis, and ISR.

  • Auditing validation protocol, method of analysis, analysis plan, TOC, and re-assay list.

  • Reviewing of technical proposals, and ensure the integrity of pharmacokinetics and statistical data.

  • Continuous training and maintaining training records of ACDIMA BioCenter personnel.

  • Reviewing and approving of qualification, validation, calibration, and preventive maintenance of all ACDIMA BioCenter instruments and equipment.

  • Reviewing and approving software validation master plan and software packages validation.

  • On-site and off-site inspections related to all clinical unit activities including screening, admission, and dosing.

  • Checking the eligibility of resources to ensure the maintenance of biological samples' integrity.