Training on Good Laboratory Practice (GLP)

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.