FDA 21 CFR Part 58

The FDA regulation for Good Laboratory Practice for Nonclinical Laboratory Studies is found in 21 CFR Part 58. It applies to nonclinical laboratory studies that support applications for research or marketing permits for products regulated by the FDA. The regulation covers General Provisions, Organization and Personnel, Facilities, Equipment, Testing Facilities Operation, Test and Control Articles, Protocol for and Conduct of a Study, Records and Reports, and Disqualification of Testing Facilities. Data must be recorded directly, promptly, and legibly in ink, dated and signed. Changes must not obscure original entries and must indicate reason, date, and responsible individual. Automated systems must identify the individual responsible for data input. Final reports must include specific required elements including facility name, study dates, objectives, statistical methods, test article identification, test system description, and animal details.

OECD Principles of GLP

The OECD Principles of Good Laboratory Practice establish quality standards for the organization and management of test facilities. They define responsibilities of test facility management, study director, study personnel, and quality assurance personnel. They establish minimum standards for facilities, equipment, standard operating procedures, documentation of raw data, study reports, and archiving. They apply to non clinical safety testing of pharmaceuticals, pesticides, cosmetics, veterinary drugs, food additives, feed additives, and industrial chemicals. OECD countries have established national GLP Compliance Monitoring Programmes that verify compliance through inspections and audits.

Health Canada GLP Requirements

Health Canada administers GLP requirements for non clinical laboratory studies conducted in Canada or submitted to Canadian authorities. These requirements align closely with OECD Principles and FDA expectations. Health Canada conducts GLP inspections of test facilities to verify compliance. Facilities must maintain proper documentation, equipment calibration, personnel training, and quality assurance oversight. Inspections may be routine or triggered by specific concerns.

MHRA GLP Requirements

The MHRA in the United Kingdom oversees GLP compliance for facilities conducting safety studies intended for regulatory submission. UK GLP requirements align with OECD principles and have been maintained following Brexit. The MHRA conducts GLP inspections and maintains a program for monitoring GLP compliance of test facilities. Inspections cover all aspects of GLP compliance including facilities, equipment, personnel, documentation, and quality assurance.

WHO GLP Guidelines

The World Health Organization publishes GLP guidelines that serve as an international reference, particularly for countries developing their regulatory frameworks. WHO GLP guidelines emphasize data quality and integrity as fundamental to regulatory decision making, establishing baseline standards for non-clinical health and environmental safety studies globally.

Study Based Audits

Study based audits examine specific studies from planning through reporting. We review the study plan, raw data, final report, and all supporting documentation. Study based audits verify that the study was conducted according to the protocol and GLP principles, that data are accurate and complete, and that the final report accurately reflects the study conduct. These audits typically cover one or more studies selected based on risk or regulatory requirements.

Facility Based Audits

Facility based audits examine the overall GLP compliance of the test facility. We review facilities, equipment, personnel, standard operating procedures, quality assurance systems, and documentation. Facility based audits verify that the facility has the systems and resources to conduct GLP studies, that personnel are properly trained and qualified, and that the quality assurance unit operates independently and effectively.

Process Based Audits

Process based audits examine specific processes or systems within the test facility. We review processes such as test article receipt and storage, sample management, equipment calibration, data management, and archiving. Process based audits verify that processes are controlled, documented, and compliant with GLP requirements.

Phase Audits

Phase audits examine specific phases of a study, such as dosing, observation, sample collection, or necropsy. These audits verify that the phase was conducted according to the protocol and GLP principles.

Data Integrity Audits

Data integrity audits examine the systems and controls that protect data accuracy and completeness. We review audit trails, access controls, electronic signatures, data backup, and data recovery. Data integrity audits verify that data are attributable, legible, contemporaneous, original, and accurate.

QA Program Audits

QA program audits examine the quality assurance unit’s structure, independence, and effectiveness. We review QA procedures, inspection records, audit trails, and report review processes.

Vendor and Supplier Audits

We audit suppliers of critical services to GLP facilities, including contract analysis laboratories, equipment calibration providers, and animal suppliers. These audits verify that suppliers meet GLP requirements and that their services are controlled.

Pre Inspection Readiness Audits

We conduct mock GLP inspections that simulate the experience of a regulatory inspection. These audits prepare your team and identify gaps before the regulator does.

Clients We Serve

We serve toxicology laboratories, bioanalytical laboratories, contract research organizations, pharmaceutical companies, biotechnology companies, chemical companies, agrochemical companies, medical device companies, animal facilities, and analytical laboratories.

Our Partners

We collaborate with animal welfare organizations, calibration providers, laboratory informatics vendors, training providers, regulatory consultants, and translation services.

Our GLP Audit Process

We follow a structured process that keeps you informed at every stage and ensures the final report is useful, defensible, and actionable.

Why Choose GxP Cellators for GLP Auditing

Contact Us for GLP Auditing Support

If you need an independent GLP audit for a laboratory, a contract research organization, or an internal study program, we are ready to help. Please contact us to discuss your requirements.