GCP Clinical Auditing

A company that conducts clinical trials on investigational medicinal products (CTIMP) or medical devices that involve the participation of human subjects, must prove that the design, study conduct, performance, monitoring, auditing, analysis and reporting, all meet the international ethical and scientific standards of Good Clinical Practice (GCP). 

Through our GCP auditing capabilities, we can provide assurance that the data and reported results are credible and accurate and that the rights, integrity, and confidentiality of trial subjects are protected. Laboratories that perform analysis of clinical trial samples must also conduct laboratory services to GCP standards.

Intertek provides many global organizations, both product development companies and contract research Organizations (CROs), with GCP auditing expertise. These services help to ensure that adoption of the principles of GCP meet international standards where trials are conducted to test both medical and non-medicinal products such as nutritional foods or cosmetics. Supporting GCP compliant human clinical trials, our GCP compliant laboratories provide a wide range of GCP bioanalysis services. Our Total Quality Assurance expertise enables you to identify and mitigate the intrinsic risk in your operations, supply chains and business processes.

Intertek's GCP Quality Assurance services:

• Document review and audit for example SOPs, Clinical GCP Protocols and Reports
• Audits of submission for ethical approval for GCP clinical trials
• Facility Inspections
• Critical Phase inspections of clinical studies
• System audits
• Sub-contractor audits (laboratories, archives, waste contractors)

Intertek's QA services also include:

• Preparation for ISO 9001 (Quality Management Standard) inspections
• Inspection to ensure compliance with the Human Tissue Act (HTA) 2004 and preparation for a HTA regulatory inspection

QA audit reports and compliance statements can be provided as appropriate.