GCP Clinical Auditing

GCP auditing services helping clients meet the international ethical and scientific standards of Good Clinical Practice.

A company that conducts clinical trials on investigational medicinal products (CTIMP) or medical devices involving the participation of human subjects must 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 (GCP). 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 laboratory services to GCP standards.

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 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 also provides GCP Bioanalysis Services.

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.


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