FDA GCP Requirements

The FDA regulates clinical trials through 21 CFR Part 50 for protection of human subjects, 21 CFR Part 56 for institutional review boards, and 21 CFR Part 312 for investigational new drug applications. Informed consent must be obtained from each human subject before participation. The consent process must include a description of procedures, risks, benefits, alternatives, and the subject’s right to withdraw. Documentation must be signed and dated by the subject or legally authorized representative. IRBs must review and approve all clinical investigations involving human subjects.

EMA GCP Requirements

The EMA coordinates GCP requirements through the Clinical Trials Regulation, which has applied since January 2022 and replaced the Clinical Trials Directive. The regulation establishes a harmonized process for assessing clinical trial applications in the EU. Sponsors submit a single application through the Clinical Trials Information System, and a single decision is reached through a coordinated assessment procedure. This simplifies multi country trials and increases transparency. The Good Clinical Practice Inspectors Working Group coordinates GCP inspections across member states.

Health Canada GCP Requirements

Health Canada regulates clinical trials for drugs, biologics, and medical devices through the Food and Drug Regulations and the Medical Devices Regulations. Health Canada’s GCP requirements align closely with ICH GCP and FDA expectations. Clinical trial applications must be submitted and authorized before the trial begins. The application must include the protocol, investigator brochure, consent forms, and information about the investigational product. Health Canada conducts GCP inspections of clinical trial sites, sponsors, and contract research organizations.

MHRA GCP Requirements

The MHRA regulates clinical trials of investigational medicinal products in the United Kingdom through the Medicines for Human Use (Clinical Trials) Regulations. Following Brexit, the UK maintains its own clinical trials framework while continuing to align with international GCP standards. The MHRA conducts GCP inspections as part of its oversight of clinical trials. These inspections may be triggered by the clinical trial authorization process, by concerns raised during trial conduct, or as part of a routine inspection program.

WHO GCP Guidelines

The World Health Organization publishes GCP guidelines that serve as an international reference. The WHO GCP guideline is aligned with ICH GCP and is used by many countries as the basis for their own requirements. WHO GCP guidelines address the responsibilities of sponsors, investigators, ethics committees, and regulatory authorities. They also provide guidance on trial design, conduct, analysis, and reporting.

ICH GCP Guidelines

The International Council for Harmonisation publishes the consolidated guideline for Good Clinical Practice. ICH GCP is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve human subjects. Compliance with this standard provides public assurance that the rights, safety, and well being of trial subjects are protected and that clinical trial data are credible.

Investigator Site Audits

Site audits are the most common form of GCP audit. We assess whether the site has the facilities, staff, and processes to conduct the trial correctly and whether the trial is actually being conducted that way. Our reviews cover investigator qualifications, training, delegation of authority, IRB or IEC approval, informed consent process, subject eligibility and randomization, protocol compliance, investigational product accountability, source documents and case report form accuracy, safety reporting, and essential document maintenance.

Sponsor Oversight Audits

Sponsors carry ultimate responsibility for the trials they run, even when they delegate activities to CROs. We audit sponsor oversight systems to confirm that delegation is properly managed. Our reviews cover vendor selection and qualification records, vendor oversight and performance metrics, issue escalation and governance meetings, trial master file completeness and quality, risk based monitoring plans and execution, safety management and reporting timelines, data management and query management, and clinical study reports accuracy.

CRO and Vendor Audits

We audit CROs and clinical service vendors on behalf of sponsors. Our reviews cover clinical monitoring and site management, data management and statistical analysis, safety and pharmacovigilance, central laboratory services, interactive response technology and randomization systems, electronic data capture and clinical trial management systems, and medical writing and regulatory submissions.

Phase One Unit Audits

Early phase units require particular attention because of the intensive monitoring and high risk nature of first in human studies. We audit these units for volunteer recruitment and screening processes, consent for healthy volunteers and special populations, intensive pharmacokinetic sampling and processing, safety monitoring and emergency response capability, pharmacy and investigational product handling, and overnight stay facilities and participant safety.

Data Integrity and Technology Audits

Clinical trials depend heavily on electronic systems. We assess the validation status, access controls, and audit trails of the technology platforms that hold your trial data. Key systems include electronic data capture, electronic informed consent, eSource and ePRO, randomization systems, safety databases, and trial master file systems.

Clients We Serve

We serve pharmaceutical sponsors, biotechnology sponsors, contract research organizations, investigator sites, site management organizations, institutional review boards, data management companies, central laboratories, safety and pharmacovigilance providers, and medical device sponsors.

Our Partners

We collaborate with clinical research associations, training providers, technology vendors, regulatory consultants, translation services, and legal advisors.

Our GCP Audit Process

We follow a systematic clinical auditing methodology that ensures seamless oversight from initial risk-based planning through to verified CAPA closure.

Why Choose GxP Cellators for GCP Auditing

We offer auditors with practical clinical operations and monitoring experience, ensuring multi-framework regulatory coverage across ICH GCP, FDA, EMA, Health Canada, MHRA, and WHO guidelines with risk-based sampling and strict data confidentiality.

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Contact Us for GCP Auditing Support

If you are preparing for a sponsor audit, a regulatory inspection, or an internal quality review, our GCP auditing team can help. Reach out to us to discuss your project requirements. Your inquiry will be handled with complete confidentiality and a prompt response.