Good Laboratory Practice Course

Lesson 1 • Regulatory Framework Overview

Surveys the international regulatory bodies and guidance documents that govern GLP. Provides the compliance landscape students will navigate throughout the course.

Lesson 2 • Key Terminology and Definitions

Introduces standardised GLP vocabulary essential for accurate communication. Precise terminology underpins every subsequent chapter in the course.

Lesson 3 • Core GLP Principles and Scope

Defines the fundamental principles governing non-clinical safety studies. Establishes scope boundaries that determine which studies require GLP compliance.

Lesson 1 • Principal Investigator Role at Test Sites

Explains the principal investigator's delegated responsibilities at multi-site studies. Distinguishes PI authority from study director authority established in the prior section.

Lesson 2 • Test Facility Management Obligations

Outlines the non-delegable duties of facility management under GLP. Anchors the accountability hierarchy introduced in Chapter 1 terminology.

Lesson 3 • Sponsor Responsibilities and Oversight

Defines sponsor obligations when commissioning GLP studies. Establishes the sponsor-facility relationship as a compliance partnership.

Lesson 4 • Study Director Authority and Duties

Details the study director's singular responsibility for overall study conduct. Clarifies decision-making authority relative to other roles.

Lesson 1 • QA Unit Structure and Independence

Establishes the organisational independence required for an effective QA unit. Independence from study conduct is the foundation of credible QA oversight.

Lesson 2 • Study-Based Inspections

Covers planning and executing inspections tied to specific study phases. Connects inspection timing to critical study events identified in study plans.

Lesson 3 • QA Reporting and Management Communication

Details the formal reporting obligations QA has to management and study directors. Ensures findings reach decision-makers who can authorise corrective action.

Lesson 4 • Corrective and Preventive Action Systems

Introduces CAPA processes for resolving QA findings and preventing recurrence. Closes the compliance loop started by inspection activities.

Lesson 1 • Facility Design and Environmental Controls

Covers spatial separation, environmental monitoring, and contamination prevention in GLP facilities. Physical design directly affects study integrity and animal welfare.

Lesson 2 • Equipment Qualification and Calibration

Details installation, operational, and performance qualification for laboratory equipment. Calibrated equipment is prerequisite to reliable raw data generation.

Lesson 3 • Electronic Records and Audit Trails

Addresses requirements for electronic raw data, audit trails, and system access controls. Builds on validation concepts to ensure data traceability.

Lesson 4 • Reagents, Reference Standards, and Test Items

Covers labelling, storage, and characterisation requirements for all study materials. Proper material management prevents confounding of study results.

Lesson 1 • Purpose and Scope of SOPs in GLP

Explains why SOPs are mandatory under GLP and which activities they must cover. Frames SOPs as the operational backbone of a compliant facility.

Lesson 2 • SOP Version Control and Distribution

Manages the lifecycle of SOPs from issuance through revision and retirement. Version control ensures personnel always use current authorized procedures.

Lesson 3 • Writing Effective SOPs

Provides a structured approach to drafting clear, actionable SOPs. Well-written SOPs reduce procedural errors and support consistent data generation.

Lesson 1 • Study Plan Content Requirements

Identifies all mandatory elements of a GLP-compliant study plan. The study plan is the primary contractual and scientific document governing study conduct.

Lesson 2 • In-Study Data Collection and Management

Addresses real-time recording of raw data and in-study oversight obligations. Accurate in-study data collection is the foundation of a defensible final report.

Lesson 3 • Study Plan Amendments

Covers the process for formally modifying approved study plans during study conduct. Amendments maintain scientific and regulatory traceability of changes.

Lesson 4 • Study Termination and Completion

Covers procedures for planned and unplanned study termination, including documentation requirements. Proper closure ensures all data and specimens are preserved.

Lesson 1 • Archive Design and Management

Covers physical and electronic archive requirements for GLP study materials. Proper archives enable reconstruction of any study long after completion.

Lesson 2 • Final Report Amendments and Corrections

Addresses post-issuance changes to final reports through formal amendment procedures. Amendments preserve the scientific record without invalidating original findings.

Lesson 3 • Data Integrity Principles and ALCOA+

Applies the ALCOA+ framework to all GLP data throughout the study lifecycle. Data integrity is the unifying principle connecting every prior chapter.

Lesson 4 • Retention Periods and Material Disposition

Defines minimum retention periods for raw data, specimens, and reports. Retention planning must account for regulatory and sponsor requirements simultaneously.

Lesson 1 • Managing the Inspection Process

Covers opening meetings, escort protocols, and real-time response during inspections. Effective management minimizes disruption and supports accurate inspector findings.

Lesson 2 • Inspection Preparation and Readiness

Provides a systematic approach to pre-inspection preparation across all GLP elements. Readiness programs reduce findings and demonstrate a culture of compliance.

Lesson 3 • Responding to Inspection Findings

Guides facilities through formal response to inspection reports and finding classifications. Timely, substantive responses demonstrate regulatory commitment.

Lesson 4 • Maintaining Continuous Inspection Readiness

Establishes ongoing programs that sustain compliance between regulatory inspections. Continuous readiness integrates QA, training, and management review activities.