GCP Clinical Auditing
Depending on its quality system and industry requirements, each business has unique quality standards and practices. While the purpose of all audits is the same, the elements and steps involved in the audit process may differ depending on the type of audit required and its applied regulation standards.
Intertek has decades of experience in quality management and compliance services spanning over a wide spectrum of industries. We can design audit and action plans to accommodate your needs, be they EC standards, OECD, FDA regulations, or WHO concerns. In the audit process, Intertek "photographs" the company's existing quality system, and superimposes it on the reference system. This allows an exact assessment on the company's conformity performance. Intertek then recommends a plan of action, which allows the company to achieve the quality assurance required. A plan may include corrective actions on:
- Documentation and Record control
- Facility and Equipment control
- Staff Training
Working with the company, Intertek takes an active role to ensure corrective actions are instituted and implemented.
Good Clinical Practice (GCP)
A company that conducts clinical trials on investigational medicinal products (CTIMP) or medical devices involving the participation of human subjects must be able to prove that the design, study conduct, performance, monitoring, auditing recording, analysis and reporting of studies meet international ethical and scientific standards of Good Clinical Practice. The aim is to 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 the analysis or evaluation of clinical trial samples must also conduct such support work to GCP.
Many enlightened organizations also adopt the principles of GCP when using healthy human volunteers to test non-medicinal products e.g. nutritional foods, cosmetics/personal products.
Intertek's GCP QA services include:
- 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 prepare for a HTA regulatory inspection
QA audit reports and compliance statements can be provided as appropriate.
Request more information to see how Intertek can help your organization with GCP Clinical Auditing.