Good Laboratory Practices for Nonclinical Safety Studies
Comprehensive online GLP training aligned with MHRA requirements, the Good Laboratory Practice Regulations 1999, OECD Principles of GLP, and international standards — trusted by UK pharmaceutical, chemical, and biotechnology professionals. Self‑paced. 21 CFR Part 11 compliant certificates. Inspection‑ready training records.
5+ GLP Courses | 21 CFR Part 11 Compliant Certs | 4+ Regulatory Frameworks | MHRA & OECD Aligned
Regulatory Context
GLP Compliance in the UK: MHRA, GLP Regulations & International Standards
The United Kingdom has a comprehensive regulatory framework for Good Laboratory Practice (GLP) that is based on the OECD Principles of GLP and implemented through the Good Laboratory Practice Regulations 1999 (SI 3106) . The Good Laboratory Practice Monitoring Authority (GLPMA), part of the Medicines and Healthcare products Regulatory Agency (MHRA), is responsible for administering the UK GLP Compliance Monitoring Programme.
Key Regulatory Frameworks:
| Regulatory Authority | Framework | Application |
| MHRA | Good Laboratory Practice Regulations 1999 (SI 3106) | UK implementation of OECD GLP Principles |
| MHRA | GLP Compliance Monitoring Programme | Routine biennial inspections of test facilities |
| OECD | OECD Principles of GLP (as revised in 1997) | Mutual Acceptance of Data (MAD) |
| European Union (applicable) | Directives 2004/9/EC and 2004/10/EC | EU GLP framework (applicable where retained) |
Key Requirements:
- The Good Laboratory Practice Regulations 1999 apply to those test facilities that conduct or intend to conduct a regulatory study
- Laboratories and other facilities that do regulatory studies are subject to routine biennial inspection
- Membership of the GLP compliance programme is mandatory for such organisations
- All work must be done in accordance with the principles of GLP
- Prospective members are required to complete an application form and send it to [email protected]
The OECD has a series of documents on the principles of GLP and compliance monitoring, available at the OECD website. The UK GLPMA normally gives at least 10 working days’ notice of inspections.
Our Courses
GLP Training Courses — MHRA & OECD Aligned
All courses are self‑paced, available online, and include 21 CFR Part 11 compliant certificates with verifiable IDs — accepted as documented training records during MHRA and other regulatory inspections.
Most Popular for UK GLP Professionals
Good Laboratory Practices (OECD Focused)
Price: $149.00
This comprehensive training program offers an in‑depth examination of the OECD Principles of Good Laboratory Practice (GLP), as revised in 1997. Tailored for professionals in the pharmaceutical, chemical, and biotechnology sectors, the curriculum addresses the complete range of GLP requirements, including organizational responsibilities, quality assurance, study conduct, data integrity, and archival management.
The program equips participants with practical knowledge of how GLP facilitates the production of reliable, reproducible, and internationally recognized non‑clinical safety data, thereby supporting regulatory compliance, safeguarding human health, and enabling the Mutual Acceptance of Data (MAD) in global markets.
International Regulatory References:
- OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring, Number 1: OECD Principles on Good Laboratory Practice (as revised in 1997) – ENV/MC/CHEM (98)17
- OECD Council Act C(81)30(Final): Decision of the Council concerning the Mutual Acceptance of Data in the Assessment of Chemicals
- OECD Council Act‑Recommendation C(89)87(Final): Decision‑Recommendation of the Council on Compliance with Good Laboratory Practice
- UK Good Laboratory Practice Regulations 1999 (SI 3106)
Target Audience:
- Laboratory Technicians and Study Personnel
- Study Directors and Principal Investigators
- Quality Assurance (QA) Professionals
- Test Facility and Test Site Management
- Regulatory Affairs Specialists
- Sponsors
- New Employees in pharmaceutical, pesticide, chemical, and biotechnology industries
Certification:
Learners who successfully complete the program will receive a dated, traceable certificate that provides verifiable proof of their achievement for professional records.
Curriculum: 12 Sections – 12 Lessons – Lifetime Access
Enroll in Good Laboratory Practices (OECD Focused)
OECD Good Laboratory Practice (GLP) Training | GxP Trainings
GLP Internal Auditor Certification (OECD Focused)
Price: $599.00
This training program defines the complete knowledge and performance requirements for personnel within a nonclinical laboratory testing facility to become certified internal auditors for Good Laboratory Practice (GLP) as prescribed in the OECD Principles of Good Laboratory Practice (as revised in 1997) . The program integrates GLP requirements for single‑site and multi‑site studies with internal auditing practices based on ISO 19011.
Operational areas covered:
- Test Facility Organisation and Personnel – test facility management responsibilities, Study Director responsibilities, Principal Investigator responsibilities (for multi‑site studies), study personnel responsibilities
- Quality Assurance Programme – independence from study conduct, study‑based inspections, facility‑based inspections, process‑based inspections, QA statement in final report
- Facilities – general requirements, test system facilities, facilities for handling test and reference items, archive facilities, waste disposal
- Apparatus, Material and Reagents – design, calibration, maintenance, labelling, expiry date management
- Test Systems – physical/chemical systems, biological systems (animals, plants), acclimatisation, isolation, health evaluation
- Test and Reference Items – receipt, handling, sampling, storage, characterisation, stability, homogeneity, batch retention
- Standard Operating Procedures – availability, approval, deviations, historical file
- Performance of the Study – study plan, study plan amendments, study plan deviations, conduct of the study, raw data recording, data changes, audit trails
- Reporting of Study Results – final report content, QA statement, Study Director signature, amendments
- Storage and Retention of Records and Materials – archives, retention periods, indexing, access control
- Multi‑Site Study Management – Principal Investigator role, communication, master schedule, study plan for multi‑site studies, delegation of phases
- Auditing practices – audit programme management, audit planning, checklist design, evidence collection, sampling, working papers, non‑conformity classification, report writing, management notification, CAPA tracking, effectiveness verification, and audit closure
Learning Objectives:
- Interpret and apply all OECD Principles of GLP to single‑site and multi‑site nonclinical laboratory studies
- Understand and apply the seven quality management principles in the context of GLP
- Plan, manage, and execute internal audits in full accordance with auditing guidelines
- Develop audit checklists, sampling plans, and audit protocols tailored to OECD GLP requirements
- Collect objective evidence through interviews, observation, and document review
- Identify and classify non‑conformities as major, minor, or observation with clear justification
- Write non‑conformity reports that are factual, complete, and actionable
- Prepare and distribute audit reports to appropriate management levels
- Notify management of critical findings using escalation procedures
- Track CAPA using a formal CAPA tracking log with status codes
- Verify the effectiveness of corrective and preventive actions
- Close an audit properly with a closure memo and management acknowledgment
- Understand the unique requirements of multi‑site studies
Target Audience:
- Quality Assurance Personnel
- Internal Auditors (both existing and prospective)
- Study Directors
- Testing Facility Management
- Archivists
- Laboratory Supervisors
- Sponsor Representatives
Prerequisites:
- Completion of basic GLP awareness training of at least four hours or equivalent on‑the‑job experience
- At least six months of experience in a nonclinical laboratory testing facility
Enroll in GLP Internal Auditor Certification (OECD Focused)
OECD GLP Internal Auditor Certification Course | GxP Trainings
Additional GLP Training Courses
GLP Internal Auditor Certification (FDA Focused)
Price: $599.00
This self‑study training program defines the complete knowledge and performance requirements for personnel within a nonclinical laboratory testing facility to become certified internal auditors for Good Laboratory Practice (GLP) as prescribed in 21 CFR Part 58. The program integrates GLP requirements for nonclinical laboratory studies with internal auditing practices based on ISO 19011.
Operational areas covered:
- Facilities – animal care areas, animal supply areas, test and control article handling areas, laboratory operation areas, specimen and data storage facilities
- Equipment – design, maintenance, calibration, and inspection requirements
- Testing facility operations – standard operating procedures, reagents and solutions, animal care
- Test and control articles – characterization, handling, and mixtures with carriers
- Protocol and conduct of studies – protocol approval, changes, and study conduct
- Records and reports – final reporting, storage and retrieval, retention requirements
- Quality assurance unit – responsibilities, inspections, reporting, independence from study conduct
- Personnel and management – training, job descriptions, study director responsibilities, management obligations
- Auditing practices – audit programme management, audit planning, checklist design, evidence collection, sampling, working papers, non‑conformity classification, report writing, management notification, CAPA tracking, effectiveness verification, and audit closure
Target Audience:
- Quality Assurance Unit Personnel
- Internal Auditors
- Study Directors
- Testing Facility Management
- Archivists
- Laboratory Supervisors
- Sponsor Representatives
Prerequisites:
- Completion of basic GLP awareness training of at least four hours or equivalent on‑the‑job experience
- At least six months of experience in a nonclinical laboratory testing facility
Enroll in GLP Internal Auditor Certification (FDA Focused)
GLP Internal Certified Auditor (FDA Focused) I GLP Training
ISO 19011:2026 – Auditing Management Systems
Price: $199.00
This comprehensive training program is designed to provide individuals with a thorough understanding of ISO 19011:2026, “Guidelines for Auditing Management Systems.” The program covers all aspects of the standard, including the principles of auditing, managing an audit programme, conducting management system audits, and evaluating the competence of individuals involved in the audit process.
Target Audience:
- Internal Auditors
- Audit Programme Managers
- Quality Managers and Quality Professionals
- Management System Practitioners
- Second‑Party Auditors
- Consultants
- Individuals Preparing for Auditor Certification
- Top Management and Leaders
Enroll in ISO 19011:2026 – Auditing Management Systems
ISO 19011:2026 Auditor Training Course Online | GxP Trainings
Who Needs GLP Training in the UK?
GLP training is a legal requirement for all personnel involved in the generation, management, and regulatory submission of non‑clinical safety data in the UK.
Laboratory Personnel
- Laboratory Technicians and Study Personnel
- Study Directors and Principal Investigators
- Analytical Chemists and Biologists
Quality & Compliance
- Quality Assurance (QA) Professionals
- Internal Auditors
- Regulatory Affairs Specialists
- Compliance Officers
Management
- Test Facility Management
- Laboratory Supervisors
- Archivists and Data Managers
Sponsors & Contract Research Organisations
- Sponsors commissioning non‑clinical studies
- Contract Research Organisation (CRO) personnel
GLP Inspections, Compliance Risk & Training Records
What Happens When GLP Training Falls Short
The Good Laboratory Practice Monitoring Authority (GLPMA), part of the MHRA, is responsible for administering the UK GLP Compliance Monitoring Programme. Laboratories and other facilities that do regulatory studies are subject to routine biennial inspection. Inspection findings can have serious consequences:
- Non‑compliance statements affecting the acceptance of study data
- Rejection of study data in regulatory submissions
- Suspension or revocation of GLP compliance status
- Legal action under the Good Laboratory Practice Regulations 1999
Common MHRA GLP inspection observations include:
- Inadequate personnel training and documentation
- Insufficient quality assurance oversight
- Poor documentation practices and data integrity issues
- Inadequate facilities and equipment maintenance
The UK GLP Compliance Monitoring Programme
The UK GLP Compliance Monitoring Programme is mandatory for organisations that conduct regulatory studies. All work must be done in accordance with the principles of GLP. Prospective members are required to complete an application form and send it to [email protected].
Members of the UK GLP Monitoring Programme should conduct a documented review of their existing data integrity processes to ensure they fully comply with OECD requirements.
Inspection‑Ready Training Records
Our 21 CFR Part 11 compliant certificates provide auditable, documented training records that MHRA inspectors accept during inspections.
- Unique verifiable certificate ID — check at gxptrainings.com/verify-certificate/
- Includes completion date, course name, and assessment score
- Downloadable PDF — upload to any QMS or LMS
- Accepted by MHRA inspectors
- Satisfies OECD GLP and Good Laboratory Practice Regulations 1999 training requirements
Why Choose GxP Trainings for GLP
| Feature | GxP Trainings |
| Good Laboratory Practice Regulations 1999 aligned | ✓ |
| MHRA GLP Compliance Monitoring Programme aligned | ✓ |
| OECD Principles of GLP aligned | ✓ |
| 21 CFR Part 58 (FDA GLP) covered | ✓ |
| ISO 19011 auditing principles covered | ✓ |
| 21 CFR Part 11 compliant certificate | ✓ |
| Self‑paced — study on your schedule | ✓ |
| Instant certificate download | ✓ |
| Verifiable certificate ID | ✓ |
| Group / corporate enrollment | ✓ |
Frequently Asked Questions
Q: Is online GLP training accepted by the MHRA?
Yes. The MHRA does not mandate a specific training delivery format. What matters is that training is documented, role‑appropriate, and effective. Our 21 CFR Part 11 compliant certificates provide verifiable proof of training that MHRA inspectors accept during inspections.
Q: What is the UK GLP Compliance Monitoring Programme?
The UK GLP Compliance Monitoring Programme is administered by the GLPMA (part of the MHRA) and involves routine biennial inspections of laboratories and other facilities that conduct regulatory studies. Membership of the programme is mandatory for such organisations.
Q: What is the difference between the OECD Focused and FDA Focused GLP Internal Auditor courses?
The OECD Focused course is based on the OECD Principles of GLP (as revised in 1997), which form the basis for UK GLP requirements. The FDA Focused course is based on 21 CFR Part 58, which is specific to FDA requirements. Both courses provide comprehensive internal auditor training.
Q: What are the prerequisites for the GLP Internal Auditor courses?
Completion of basic GLP awareness training of at least four hours or equivalent on‑the‑job experience, and at least six months of experience in a nonclinical laboratory testing facility.
Q: Do you offer group discounts for UK companies?
Yes. We offer corporate and group enrollment options for teams of all sizes. Contact us for a custom quote.
Q: How long do I have access to the course?
All courses include lifetime access — study at your own pace, on your own schedule.
Q: Are the certificates verifiable?
Yes. Each certificate includes a unique verifiable ID that can be checked at gxptrainings.com/verify-certificate/
UK GLP Compliance Summary
The UK regulatory framework for GLP is based on the OECD Principles of GLP and implemented through the Good Laboratory Practice Regulations 1999.
Good Laboratory Practice Regulations 1999 (SI 3106)
The Good Laboratory Practice Regulations 1999 apply to those test facilities that conduct or intend to conduct a regulatory study.
Key Requirements:
- Regulation 3: Sets out the arrangements for enforcing compliance with the Regulations by the GLPMA
- Regulation 4: Contains a requirement that regulatory studies must only be conducted at test facilities which are part of the UK GLP compliance programme
- Regulation 6: Defines membership of the UK GLP compliance programme
- Regulation 7: Requires that no person shall conduct a regulatory study unless the principles of good laboratory practice are adhered to
OECD Principles of GLP
The OECD Principles of Good Laboratory Practice (as revised in 1997) form the basis for GLP compliance in the UK.
Key Principles:
- Test Facility Organisation and Personnel – clear responsibilities for management, study directors, and study personnel
- Quality Assurance Programme – independent monitoring of studies
- Facilities – adequate facilities for test systems, test items, and archives
- Apparatus, Material and Reagents – proper design, calibration, and maintenance
- Test and Reference Items – proper receipt, handling, sampling, and storage
- Standard Operating Procedures – written procedures for all activities
- Performance of the Study – study plan and conduct
- Reporting of Study Results – final report with QA statement
- Storage and Retention of Records – secure archives with proper retention periods
All GxP Trainings courses referenced above are designed to align with the UK Good Laboratory Practice Regulations 1999, MHRA GLP Compliance Monitoring Programme, OECD Principles of Good Laboratory Practice, and international GLP standards.