GLP Certification in Japan:

GLP Implementation Process in Japan

GLP implementation in Japan follows a structured, inspection-driven approach aligned with OECD GLP Principles and PMDA expectations. The process begins with a detailed GLP gap assessment and risk analysis of existing laboratory practices.

Based on identified gaps, laboratories develop a GLP Quality Manual, SOPs, and study-specific templates, followed by the establishment of an independent Quality Assurance (QA) unit with appropriate training.

GLP systems are rolled out across ongoing and new studies, supported by internal audits and mock inspections. Corrective actions are implemented to achieve full inspection readiness. For domestic facilities, PMDA routine inspections are voluntary and result in GLP certification.

GLP Inspections and Audits in Japan

PMDA conducts three types of GLP inspections:

• Routine inspections – voluntary for domestic facilities, certificate issued
• Product-based inspections – mandatory for marketing authorization applications
• Special inspections – triggered by concerns or critical submissions

Inspections focus heavily on data integrity, QA independence, study conduct, and computerized systems. Reviews include facility audits and detailed study inspections.

Identified findings are addressed through CAPA; re-inspections may occur if required. Common issues include unvalidated systems and weak deviation handling.

GLP Certification Timeline in Japan

• Small laboratories: 6–12 months
• Medium CROs: 12–18 months
• Large or multi-site facilities: 18–24 months

Timelines depend on study volume, documentation maturity, and digital system readiness. Certification renewal occurs every three years.

Cost Considerations for GLP in Japan

GLP implementation costs vary based on:

• Laboratory size and operational complexity
• QA staffing requirements
• Documentation gaps
• Computerized system validation needs

While small labs incur moderate costs, multi-site operations require higher investment. Digital upgrades add expense but ensure long-term compliance and inspection success. A GLP gap assessment provides the most accurate cost estimate.

Common GLP Challenges in Japan

• Over-documentation misaligned with actual operations
• Limited QA authority and independence
• Unvalidated spreadsheets and LIMS
• Poor deviation and CAPA management
• Archiving and long-term data retention issues
• Conflicts between GLP, ISO 17025, and GMP systems

Increased competition from non-MAD countries such as China intensifies inspection pressure on Japanese facilities.

Regulatory Framework for GLP in Japan

Japan’s GLP regulations are governed under the Pharmaceuticals and Medical Devices Act, enforced by PMDA and overseen by MHLW.

Japan has been a participant in the OECD Mutual Acceptance of Data (MAD) system since 1964. GLP data from OECD member countries is automatically accepted, reducing barriers for multinational submissions.

Studies Covered Under GLP

GLP applies to non-clinical safety studies including:

• Toxicology and safety pharmacology
• Pharmacokinetics and ADME
• Genotoxicity and carcinogenicity
• Medical device biocompatibility
• Agrochemical and environmental safety studies (CSCL GLP)

Who Needs GLP Compliance in Japan?

• Pharmaceutical and biopharmaceutical laboratories
• Contract Research Organizations (CROs)
• Medical device testing facilities
• Agrochemical and environmental laboratories
• Academic and government research institutions
• Japanese subsidiaries of multinational companies

Benefits of GLP Certification

• PMDA submission readiness
• Global acceptance of data via OECD MAD
• Reduced re-testing and development costs
• Improved sponsor and regulator confidence
• Competitive advantage in Asia-Pacific CRO markets

Why Vertex Certifiers for GLP Certification in Japan

Vertex Certifiers delivers OECD-aligned, PMDA-focused GLP implementation with end-to-end support including gap assessment, documentation, QA setup, training, mock inspections, and inspection support.

Our remote and onsite consulting models across Asia-Pacific enable laboratories and CROs to achieve practical, inspection-ready GLP systems—not template-based compliance.

Frequently Asked Questions – GLP in Japan

• Is GLP mandatory in Japan? Yes, for PMDA safety study submissions.
• Does PMDA issue certificates? Yes, valid for three years.
• Can GLP integrate with ISO 17025? Yes, through shared systems.
• Are electronic records accepted? Yes, if properly validated.