Training on Good Laboratory Practice (GLP)

Reliable laboratory results are essential for research credibility, regulatory approval, and operational excellence. Good Laboratory Practice (GLP) provides a structured framework that ensures laboratory processes are consistent, traceable, and compliant with international standards.

This course delivers a comprehensive understanding of GLP principles and their application in laboratory environments, focusing on the systems and controls required to produce high-quality and reproducible results. Participants will explore the core components of GLP, including organizational structure, roles and responsibilities, documentation systems, and quality assurance processes.

The training emphasizes the development and implementation of standard operating procedures (SOPs), ensuring that laboratory activities are standardized, well-documented, and consistently executed. Participants will also gain practical skills in maintaining data integrity, including accurate recording, validation, storage, and protection of laboratory data throughout its lifecycle.

In addition, the course addresses regulatory compliance requirements aligned with internationally recognized frameworks such as OECD GLP and ISO/IEC 17025. Participants will learn how to prepare for audits and inspections, manage deviations, and implement corrective and preventive actions (CAPA) to maintain continuous compliance.

Through practical examples and case-based learning, participants will strengthen their ability to manage laboratory operations, enforce quality systems, and build a culture of accountability and excellence in testing and research environments.

Duration

 5 Days

Who Should Attend

• Laboratory Managers and Supervisors
• Quality Assurance and Quality Control Officers
• Research Scientists and Technicians
• Regulatory Affairs Professionals
• Auditors and Compliance Officers in testing and research environments

Organization Impact

• Strengthens laboratory credibility and trust through compliance with international standards.

• Enhances data reliability, consistency, and reproducibility.

• Reduces audit failures and improves regulatory readiness.

• Builds a sustainable culture of quality, safety, and accountability.

Individual Impact

• Develops expertise in implementing and maintaining GLP systems.

• Improves competence in laboratory quality assurance and compliance.

• Enhances professional credibility in regulated environments.

• Expands career opportunities in research, testing, and regulatory industries.

By the end of this course, participants will be able to:

• Understand the principles and purpose of GLP.

• Implement effective quality management systems in laboratories.

• Maintain accurate documentation and traceability of experimental data.

• Ensure compliance with OECD, WHO, and ISO standards.

• Prepare for and manage internal and external laboratory audits.

Module 1: Introduction to Good Laboratory Practice

• History, scope, and objectives of GLP.

• The role of GLP in research and regulatory compliance.

• International frameworks: OECD, WHO, and ISO standards.
  Case Study: Implementing GLP in a newly accredited testing laboratory.

Module 2: Quality Systems and Organizational Structure

• Essential components of a laboratory quality system.

• Roles and responsibilities under GLP.

• Quality assurance versus quality control.

• Establishing a quality culture and accountability.
  Case Study: Strengthening QA systems to reduce non-conformities in laboratory audits.

Module 3: Standard Operating Procedures (SOPs) and Documentation

• Developing, maintaining, and controlling SOPs.

• Data recording, integrity, and traceability requirements.

• Managing deviations, errors, and corrective actions.

• Record retention and archiving protocols.
• Case Study: Managing documentation errors during a regulatory inspection.

Module 4: Equipment, Materials, and Calibration Management

• Equipment validation, calibration, and maintenance schedules.

• Supplier and material qualification processes.

• Environmental monitoring and control in laboratory operations.
  Case Study: Addressing calibration failures to maintain GLP compliance.

Module 5: GLP Compliance, Inspections, and Audits

• Preparing for GLP inspections and audits.

• Handling non-compliance findings and corrective actions.

• Continuous improvement in laboratory quality systems.

• Integrating risk management into laboratory operations.
  Case Study: Lessons learned from an OECD GLP compliance inspection.