Global Auditing Service Menu
GLP Audit
GCP Audit
GMP/GQP Audit
Pharmaceutical factories, raw material manufacturing, cosmetics
GVP/GPSP Audit
Post-marketing safety information management
Global Auditing Services provides specialized audit solutions across the life sciences sector, including nonclinical studies, clinical trials, GMP/GQP, and pharmacovigilance (GVP/GPSP).
Our audits are tailored to international regulations and standards, with flexible formats such as on-site, remote, or simplified audits. We cover GLP facility audits, multisite studies, and GCLP (Good Clinical Laboratory Practice) inspections.
In clinical trials, we audit vendors, investigator sites, clinical reports, and investigator-initiated studies. We also conduct GMP audits for drug products, APIs, excipients, packaging, medical devices, cosmetics, and regenerative medicine.Radiopharmaceutical and raw material manufacturing audits are included in our scope.
Pharmacovigilance audits cover both PV partners and vendors.
Our services are designed to ensure data integrity, regulatory compliance, and operational quality. With global experience and deep industry expertise, we offer audit strategies tailored to each project.
1. Nonclinical Testing/GLP-Related Audit Services
1.1. GLP Testing Facility Audits
We provide services for auditing GLP compliance at facilities conducting GLP toxicology studies, including toxicokinetic (TK) studies, as well as retrospective audits to assess the reliability and quality of GLP study final reports.
1.2. Multisite Studies
In cases where a portion of a GLP study—such as toxicokinetics measurement, test substance analysis, pathological specimen preparation, or other specialized test items—is outsourced by the study sponsor to a third party, audits can be conducted upon request to evaluate the facility’s GLP compliance and retrospectively review study reports.
1.3. Non-GLP Testing Facility Audits
Audits can be conducted for facilities performing various nonclinical studies, including pharmacology, pharmacokinetics, and exploratory ADMET, which are classified as non-GLP studies. For example, our company has experience evaluating the reliability of pharmacology study data conducted at U.S. universities.
1.4. GCLP (GCP for Laboratories)
As part of our GCP auditing activities, we perform inspections of analytical laboratories involved in the measurement of clinical trial samples.
2. Clinical Trials/Research/GCP-Related Audit Services
2.1. Overview of GCP Audit Services
Our GCP-related audit services primarily focus on vendor audits—including those of CROs—and audits of clinical trial sites. However, the scope and structure of the service may vary depending on the audit subject and the entity conducting it.
2.2. Vendor Audits for Clinical Trials
When initiating a clinical trial, it is common to delegate various operational tasks to a Contract Research Organization (CRO). These tasks may include monitoring, medical writing, data management, statistical analysis, and other trial-related activities.
2.3. Audit of Investigator Sites
Audit Service for Clinical Trial Sites (Hospitals)
This audit service is designed for hospitals conducting clinical trials.
Key aspects of the audit include reviewing essential trial documentation such as the Investigator Site File (ISF), records related to Institutional Review Board (IRB), Study Administration Office files (if separately maintained), and Investigational Product management documentations.
2.4. In-Process Audits During Clinical Trials
Comprehensive Audit Service to Ensure Trial-Wide Quality
This audit service is designed to oversee the end-to-end process of clinical trials and ensure overall quality.
It combines audits of clinical trial sites with on-site or remote audits of CROs during the trial period.
2.5. Audit Services for Investigator-Initiated Trials and Clinical Research
This service is provided upon request from hospitals or administrative offices overseeing investigator-initiated trials or clinical research. While the scope of the audit is generally equivalent to that conducted for industry-sponsored clinical trials, it is often carried out using templates developed by medical associations.
2.6. Audit of Clinical Study Reports
Audit services for clinical study reports are offered at two distinct levels depending on the specific objectives:
1. Audit of Document Structure and Format
This audit assesses whether the report has been prepared in compliance with the ICH-E6 guidelines and the corresponding study protocol. The focus is placed on verifying the consistency of the document structure and content in alignment with the protocol requirements.
2. Audit of Data Accuracy
This audit evaluates the accuracy of the clinical trial data presented in the report, including aspects related to data management and statistical analysis. For studies with large datasets, the verification process may require additional time; however, it enables a more robust quality assurance framework.
Each audit is implemented flexibly, taking into account the scale of the trial and the contents of the report, including the optimal timing of execution.
3. GMP/GQP Factory Audits
We provide GMP/GQP audit services for manufacturing facilities in the pharmaceutical, medical device, and cosmetics industries.
3.1. GMP Audits for Drug Product Manufacturing Facilities
We provide GMP audit services for manufacturing facilities engaged in the production of drug products. Drug formulations vary widely, even within the category of pharmaceutical products. Our audit experience spans a broad range of formulation types—including transdermal patches, generic drugs, and injectable products requiring advanced environmental monitoring and controls.
3.2. GMP Audits for Active Pharmaceutical Ingredient (API) Manufacturing Facilities
We conduct GMP audits for manufacturing facilities that produce Active Pharmaceutical Ingredients (APIs). These audits are primarily based on API GMP guidelines such as ICH Q7, with EU-GMP Part II serving as the applicable regulatory standard in Europe.
3.3. Audit of Pharmaceutical Excipient Manufacturing Facilities
Manufacturing management of pharmaceutical excipients is outside the scope of formal GMP regulatory requirements. However, from a quality assurance perspective, industry-driven standards have been established to ensure appropriate controls.
3.4. Audit of Suppliers of Pharmaceutical Packaging Materials
Primary packaging materials for pharmaceuticals are directly linked to the safety and efficacy of drug products, and therefore require strict manufacturing controls in compliance with GMP standards.
3.5. Audit of Investigational Medicinal Products Manufacturing Facilities
The manufacture and management of investigational medicinal products (IMPs) are subject to country-specific GMP regulations. In Japan, the GMP Standards for Investigational Drugs apply, while in Europe, EU GMP Annex 13 serves as the regulatory framework.
3.6. Audit of Regenerative Medicine Product Manufacturing Facilities
In Japan, GCTP (Good Gene, Cellular, and Tissue-based Products Manufacturing Practice) has been implemented as the regulatory standard. Across EU and the US, quality management is also mandated under country-specific GMP and GTP regulations. The development of regenerative medicine products continues to advance rapidly, with research and innovation progressing—particularly within academic institutions in Japan.
3.7. Audit of Radiopharmaceutical Manufacturing Facilities
This service targets manufacturing facilities of diagnostic radiopharmaceuticals used in PET imaging. In recent years, the development of pharmaceuticals utilizing targeting technologies—such as contrast agents—has been steadily progressing, making this a promising area within drug development.
3.8. Audit of Medical Device Manufacturing Facilities
This service covers manufacturing sites for medical device products, where regulatory requirements based on ISO 13485 are applied. In Japan, the implementation of a Quality Management System (QMS) is mandated as a regulatory obligation.
3.9. Audit of Manufacturing Facilities for Medical Device Raw Materials
In the manufacturing of raw materials for medical devices, compliance with medical device GMP or Quality Management System (QMS) requirements may also be necessary. Specifically, in order to ensure the quality and safety of medical devices, the production processes for raw materials are often expected to conform to GMP standards—particularly for materials and components that directly impact the final product.
3.10. Audit of Manufacturing Facilities for Cosmetics and Cosmetic Ingredients
In the manufacturing of cosmetics, industry-led voluntary standards have been established both domestically and internationally.
3.11. Delegated Internal GMP Audit (Self-Inspection)
We offer delegated internal audit (self-Inspection) for GMP-compliant areas, supporting clients in strengthening their GMP practices by conducting self-inspections from a more rigorous and impartial perspective.
4. GVP/PV Audit Services
4.1. Pharmacovigilance (PV) Partner Audit
When entering into licensing agreements involving pharmaceuticals and related products, audits are conducted from the perspective of the licensor or licensee to verify whether the contractual partner is appropriately managing pharmacovigilance (PV) information.
4.2. PV Vendor Audit
In PV operations, it is increasingly common to outsource part or all of the activities to external vendors.
The types of outsourced tasks include:
- Call center services (e.g., handling of spontaneous safety reports)
- Literature search agencies (for safety information collection)
- Safety database operators (for information management and analysis)