GCP Auditing

Good Clinical Practice (GCP) audits are critical to ensuring the integrity of clinical trials for investigational products that are intended for submission to regulatory authorities. GCP auditing enables oversight measures that verify data reliability, protect participant safety, and confirm adherence to GCP regulatory requirements.

Ensuring GCP Compliance

The ICH E6 (R3) guidelines (final version adopted Jan 2025) on Good Clinical Practice, highlights supplier and vendor management as a key factor in study quality and compliance.  Sponsors are likely working with a range of suppliers, including Contract Research Organisations (CROs), investigator sites, logistics providers, IT vendors, and other niche technology companies. The new GCP guidance recommends focusing on critical quality factors related to data flow and each supplier deliverable or system, while ensuring documentation, traceability, and risk transparency throughout the study lifecycle.

Ensuing quality and compliance across this diverse vendor ecosystem, as well as new regulatory expectations for critical computerised systems, present a range of challenges for sponsors as they strive to uphold compliance while optimising resource use.

Our GCP audit services

Why choose Intertek as your independent GCP audit partner?
GCP Audit Expertise: With nearly 20 years of global experience, we support GCP audits worldwide. Our Services include: Investigator site audits, CRO audit, Phase I unit audits, and supplier/vendor audits and audit of critical systems.
Global Reach: Our senior GCP auditors are located worldwide. They have in-depth experience of conducting pharma GCP audits across study phases, facilitating communication with each audited site, often in their local language.
Flexible Audit Solutions: A flexible range of solutions include flexible private or individual pharmaceutical audit solutions, shared audits, CAPA evaluation and follow-up, audit report purchase, remote or virtual audits and support for your internal audit program.
Broader Audit Scope: Beyond GCP audits, we perform regulatory GxP (GMP, GDP, GLP, , GVP) audits and ISO (ISO 15378, ISO 9001) audits for the pharmaceutical industry 
Our Focus on Quality: We are certified ISO 9001. Quality is at the heart of our organisation and we continuously focus on improving the performance of our services in order exceed expectations of our global clients.

Our GCP auditors provide risk-based GCP compliance audits for Phase I-III clinical trials. Through our impartial, independent GCP audit expertise, we can drive detailed insights on your clinical trial vendors, laboratories and systems, to enable an unbiased assessment of your organization’s risk and compliance.  

With accurate and comprehensive audit reports, we provide the information you need to ensure that your trial data and reported results are reliable and accurate, while safeguarding the rights, integrity, and confidentiality of study participants. Our services include document reviews and audits of SOPs, clinical GCP protocols and reports; audits of submissions for ethical approval; facility inspections; critical phase inspections of clinical studies; system audits; and audits of third-party subcontractors such as laboratories, archives, and waste contractors. 

By identifying potential compliance gaps, reviewing protocols, databases and investigator sites, our auditors help you keep your trials running smoothly and fully aligned with regulatory requirements, while maintaining regulatory rigor and optimising resources. 

Partner with us to ensure the highest standards of quality and compliance throughout your clinical trials, safeguarding both data integrity and participant safety as we navigate the complexities of good clinical practice together.