What is GLP?

Good Laboratory Practice (GLP) is a quality system that ensures the reliability of nonclinical testing. It was established to assure the integrity of safety evaluation studies for pharmaceuticals and chemical substances.

GLP and Non-clinical Studies

GLP sets standards to ensure the reliability of nonclinical studies. It is applied primarily to safety studies and safety pharmacology studies, and it governs facility and equipment management, organizational structure, recordkeeping, and related procedures at test facilities. In Japan, the GLP Ministerial Ordinance is grounded in the Pharmaceutical Affairs Law, and test facilities are subject to GLP compliance inspections. Accuracy, completeness, and records retention are required. Pharmacology and pharmacokinetic studies are not required to follow GLP, but they must comply with the Criteria for Reliability. The introduction of GLP has improved the quality and reliability of nonclinical studies and strengthened drug safety assessment.

Laws related to GLP

Ministerial Ordinance on Standards for Conducting Nonclinical Studies on the Safety of Medical Devices

This ordinance ensures the reliability of nonclinical studies on the safety of medical devices. It establishes compliance requirements for biological safety studies conducted by parties seeking approval to manufacture and sell medical devices. When conducting biological safety studies for a device requiring marketing authorization, compliance with GLP is mandatory.

Ordinance for Enforcement of the Pharmaceutical Affairs Law, Article 43 (Criteria for Reliability)

This provision ensures the reliability of materials required for drug approval applications. It applies to nonclinical studies of pharmacology and pharmacokinetics. These studies are not required to be conducted under GLP, but they must meet criteria for accuracy, completeness, and records retention.

Pharmaceutical Affairs Law, Article 14, Paragraph 6

This provision concerns the reliability of materials submitted with applications for approval to manufacture and sell pharmaceuticals and related products. It requires that application materials be collected and prepared in accordance with standards specified by an ordinance of the Ministry of Health, Labour and Welfare (MHLW).

Pharmaceutical Affairs Law, Article 14-2-3, Paragraph 1

These regulations address the reliability of materials submitted with applications for marketing approval of pharmaceuticals, medical devices, and regenerative medical products. In particular, they require compliance with GLP to ensure the reliability of nonclinical study data. Nonclinical studies must be conducted, and data collected and prepared, in accordance with the standards set forth in the Pharmaceuticals GLP Ministerial Ordinance, Medical Devices GLP Ministerial Ordinance, and Regenerative Medicine Products GLP Ministerial Ordinance.

Key points for non-clinical study design in compliance with GLP

For drug discovery ventures, GLP-compliant nonclinical study design is critical. GLP compliance supports the integrity and reproducibility of study data and increases the likelihood of a more streamlined regulatory review. As an internationally recognized standard, GLP is fundamental to global drug development. In Japan, a GLP compliance inspection may be waived if a GLP compliance certificate is available. In other jurisdictions, inspections may likewise be waived when specific conditions are satisfied.

Rules for test operation

Establish clear operational governance. Define roles and responsibilities—such as the study director, test facility management, and the quality assurance (QA) unit—and maintain independence among functions to enable effective checks and balances.

The study plan must detail objectives, methods, and evaluation items and be approved before study initiation. Procedures for plan amendments should also be defined.

The QA unit monitors the testing process and verifies GLP compliance. Conduct regular inspections and audits, and implement corrective actions when deviations are identified. Maintain and follow procedures that support study reliability, including SOP maintenance, equipment and reagent control, and contemporaneous data recording and records retention.

Provisions for testing facilities and equipment

Align facility layout and capacity with the study’s type and purpose, and use zoning to prevent cross-contamination. Maintain sanitation through scheduled cleaning and disinfection.

Control environmental conditions—temperature, humidity, ventilation—with continuous monitoring and documentation, and set appropriate ranges for each study type.

Provide appropriate storage (e.g., refrigerators, freezers) for samples and reagents; manage temperature and expiration dates strictly, and employ storage methods that prevent cross-contamination.

For equipment, perform periodic inspections, maintenance, and calibration, and retain records. Establish defined response procedures for malfunctions.

GLP is important in non-clinical studies

As international benchmarks, GLP requirements are central to global drug development; therefore, a solid working knowledge of GLP is essential. In nonclinical programs, adherence to GLP underpins study reliability. The core criteria are accuracy, completeness, and records retention.