For laboratory professionals working in regulated environments, Good Laboratory Practice training is not just a career advantage—it is an essential foundation for success. But with so many topics covered in GLP training, it can be helpful to understand what the essential areas are and why they matter. At GxP Trainings, our comprehensive GLP programs cover all the critical topics that laboratory professionals need to master.
Here are the essential GLP training topics every laboratory professional should know. You can explore our full curriculum on our GLP Training catalog page.
The Regulatory Framework and OECD Principles
Understanding the regulatory framework that governs non-clinical laboratory studies is the starting point for any GLP training. This topic covers the history, purpose, and scope of GLP regulations, including the OECD Principles of GLP and FDA GLP Regulations. Professionals learn how these regulations protect public health by ensuring the reliability and integrity of study data.
Our Good Laboratory Practices (OECD Focused) course provides an in-depth examination of the OECD Principles as revised. This foundational understanding is essential for anyone working in a regulated laboratory environment.
Organization and Personnel
GLP places significant emphasis on the organization and personnel involved in study conduct. This topic covers the responsibilities of management, study directors, quality assurance personnel, and study staff. Professionals learn about the qualifications, training, and duties required for each role, as well as the importance of clear lines of accountability.
Understanding how GLP assigns responsibility is crucial for maintaining compliance. When everyone knows their role and responsibilities, the organization functions more effectively and is better prepared for inspections.
Quality Assurance and Auditing
Quality assurance is the cornerstone of GLP compliance. This topic covers the principles and practices of quality assurance in a GLP environment. Professionals learn how to conduct internal audits, review study plans and reports, and ensure that studies are conducted in accordance with GLP principles.
For those pursuing certification, our GLP Internal Auditor Certification (FDA Focused) and GLP Internal Auditor Certification (OECD Focused) programs provide comprehensive training in these areas. These programs define the complete knowledge and performance requirements for personnel within non-clinical laboratory testing facilities.
Facilities and Equipment
GLP has specific requirements for laboratory facilities and equipment. This topic covers the design, construction, and maintenance of facilities, as well as the calibration, maintenance, and validation of equipment. Professionals learn how to ensure that facilities and equipment are suitable for their intended use and that they do not compromise the integrity of study data.
Topics covered include environmental control, contamination prevention, equipment qualification, and maintenance documentation.
Test Systems, Test and Reference Items
The proper handling of test systems, test items, and reference items is critical to the validity of study results. This topic covers the receipt, handling, storage, and characterization of these materials. Professionals learn how to ensure that test systems are appropriate for the study and that test and reference items are properly identified, handled, and stored.
Understanding these requirements helps prevent errors that could compromise study results and regulatory submissions.
Standard Operating Procedures
Standard Operating Procedures are the foundation of GLP compliance. This topic covers the development, review, approval, and implementation of SOPs. Professionals learn how to write effective SOPs, ensure they are current, and verify that staff are trained on them.
SOPs cover every aspect of laboratory operations, from routine procedures to the handling of deviations. Well-written SOPs are essential for consistency, training, and audit readiness.
Study Plans and Reporting
The study plan is the blueprint for any GLP study. This topic covers the development, approval, and amendment of study plans. Professionals learn what must be included in a study plan and how to ensure that studies are conducted in accordance with the plan.
Similarly, the study report is the final deliverable of any GLP study. Professionals learn the requirements for study reports, including the content, format, and review process.
Recordkeeping and Archives
Recordkeeping is one of the most important aspects of GLP compliance. This topic covers the requirements for retaining and archiving study records, including raw data, final reports, and supporting documentation. Professionals learn about the retention periods, archive conditions, and access controls required by GLP.
Our GLP training emphasizes the importance of proper archiving for the long-term reliability and availability of study data.
Computerized Systems and Data Integrity
With the increasing use of computerized systems in the laboratory, GLP has specific requirements for their validation, security, and use. This topic covers the principles of data integrity, including the ALCOA+ principles, and the requirements for computerized systems under GLP and regulations like 21 CFR Part 11.
Professionals learn how to validate computerized systems, ensure data security, and maintain data integrity throughout the data lifecycle.
Preparing for Regulatory Inspections
The ultimate test of GLP compliance is a regulatory inspection. This topic covers the inspection process, what inspectors look for, and how to prepare effectively. Professionals learn how to respond to inspector questions, provide documentation, and manage the inspection process.
Being prepared for inspections reduces the risk of findings and demonstrates the organization’s commitment to quality and compliance.
Your Next Step
Mastering these essential GLP topics is crucial for success in regulated laboratory environments. GxP Trainings offers comprehensive programs that cover all these areas and more. Whether you are beginning your GLP journey or seeking advanced certification, we have the education you need.
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