OECD GLP Training: Run Non-clinical Studies to the Principles of Good Laboratory Practice

Opens with the question of what a regulator's safety decision is built on, and a self-rating on GLP. Covers the February 2020 statement by Germany's Federal Institute for Risk Assessment after LPT in Mienenbüttel lost its operating licence, with twenty-four LPT studies reviewed in a European glyphosate assessment. Turns it into four questions on reconstruction, study ownership, independent quality assurance and outside checks. Defines GLP as a quality system for planning, performing, monitoring, recording, archiving and reporting safety studies. Introduces RST Laboratories, a contract laboratory in Frankfurt, and study 26-041 for KLM Crop Science in Lyon, clears four myths, and outlines the thirteen modules, exercises and exam. It ends with a recap and three practice questions.

What you will be able to do

• Explain what GLP is and what it is for
• Apply four questions about trust in a study to your own facility
• Describe how the course, exercises and final exam work

Why it matters

Seeing how one facility's doubtful records forced regulators to recheck decisions shows why reconstructable studies matter.

Practice: Practice: Welcome: why GLP matters · 3 questions

Starts with how EFSA accepts GLP studies from facilities in OECD member countries and adhering non-members, and why a Frankfurt study need not be repeated abroad. Covers the 1981 OECD decision on mutual acceptance of data, with adhering non-members sharing the same rights and obligations. Explains how each country monitors its own facilities through designated authorities, inspections and study audits, and the OECD series of guidance documents. Covers the EU law: Directive 2004/10/EC, which makes the Principles law, and Directive 2004/9/EC, which sets out how compliance is verified. Ends the method by explaining how GLP differs from ISO/IEC 17025, so each is learned on its own terms. It ends with a recap and three practice questions.

What you will be able to do

• Explain mutual acceptance of data and who it applies to
• Describe how national authorities monitor GLP compliance
• Distinguish GLP from ISO/IEC 17025 accreditation

Why it matters

Knowing how the system works tells you why your study data can be accepted across countries, and what that depends on.

Practice: Practice: The OECD system and the EU GLP Directives · 3 questions

Opens with OECD position paper number eighteen on why GLP was developed in the nineteen-seventies after fraudulent safety studies were submitted to regulators. Defines a test facility as its people, premises and operational units, including every test site in a multi-site study, so that for study 26-041 it is RST in Frankfurt plus the Ghent test site. Covers what test facility management must ensure: named management, enough qualified people, approved SOPs, a quality assurance programme, a Study Director for each study, a master schedule and a named archivist. Shows RST's signed management statement and the training record management keeps for one technician. Explains what study personnel must do, from following the plan and SOPs to recording raw data promptly. It ends with a recap and three practice questions.

What you will be able to do

• Explain what test facility management must ensure under GLP
• Describe the duties of study personnel for their own data
• Check training records and the master schedule for a study

Why it matters

Clear management duties and personal data ownership let an inspector see who answers for what on one page.

Practice: Practice: Test facility management and personnel · 3 questions

Starts with OECD consensus document number eight: unless one person is responsible for a study, staff receive conflicting instructions, so there is only one Study Director at a time. Covers the Study Director's duties from start to finish: approving the study plan and amendments, assessing deviations, making sure data are fully recorded and systems validated, signing the final report with a statement of compliance, and archiving the study. Explains replacement and short absences. Shows the Principal Investigator at the Ghent test site, an analytical chemist running the dose formulation analyses for study 26-041, giving written assurance, while overall responsibility stays with the Study Director, and how RST's Study Directors plan and log their reviews. It ends with a recap and three practice questions.

What you will be able to do

• Explain the Study Director's role as single point of study control
• Describe how a phase is delegated to a Principal Investigator
• Check that overall responsibility stays with the Study Director

Why it matters

One person in control of each study prevents conflicting instructions and a study plan that is poorly put into practice.

Practice: Practice: The Study Director and the Principal Investigator · 3 questions

Opens with OECD advisory document number twenty-three of November 2022 and what the signed quality assurance statement in every final report must contain. Covers a documented programme run by people who report directly to management and take no part in the studies they inspect. Explains verifying study plans, study-based, process-based and facility-based inspections planned by risk, inspecting final reports against raw data, and prompt written reporting. Shows how the Ghent test site's own quality assurance inspects the formulation analysis for study 26-041 and reports to its Principal Investigator, management and the Study Director, and how a Melbourne test facility maps processes against inspection dates. In the exercise you plan quality assurance for a study and draft its statement. It ends with a recap, three practice questions and a practice exercise.

What you will be able to do

• Explain how GLP quality assurance stays independent of studies
• Plan study, process and facility inspections by risk
• Draft a quality assurance statement for a final report

Why it matters

Independent inspections that look at the work, not only the paperwork, find problems before the report is signed.

Practice: Practice: The quality assurance programme · 3 questions

Starts with section 3.3 of the Principles on separate rooms for receiving, storing and mixing test items, and the risk of preparing control and high-dose formulations on the same bench. Covers facilities designed to separate activities, isolate test systems and items, archive securely and handle waste. Explains apparatus that is suitable, inspected, maintained and calibrated to SOPs with records, and reagents labelled with identity, expiry and storage. Shows RST's controls for study 26-041: KLM-3 in a locked, refrigerated store with logged temperature, formulations prepared in a separate room one study at a time with controls made first, the balance log, bedding and pest control records. Ends with biological test systems isolated on arrival, acclimatised, identified and housed. It ends with a recap and three practice questions.

What you will be able to do

• Check that facilities separate activities and prevent mix-ups
• Verify that apparatus is maintained and calibrated with records
• Describe how test systems are received, identified and housed

Why it matters

Controlling rooms, balances and animals means only the test item can explain a study's result.

Practice: Practice: Facilities, apparatus and test systems · 3 questions

Opens with OECD advisory document number nineteen of 2018 on the identity, purity, composition and stability information the Principles require for a test item. Covers receiving test items with their integrity assessed, transport monitored where risk calls for it, identity verified by an agreed mechanism, a sample retained, and quantities recorded and reconciled. Shows KLM-3 arriving at RST from KLM in Lyon on 14 April with a temperature logger reading four to seven degrees and the container intact. Explains characterisation and stability for each study, the report stating who characterised the items, and determining homogeneity, concentration and stability of a test item in its vehicle. In the exercise you receive a test item, decide what to record and plan formulation analyses. It ends with a recap, three practice questions and a practice exercise.

What you will be able to do

• Check a test item's receipt, identity and reconciliation
• Explain the characterisation and stability data each study needs
• Plan homogeneity, concentration and stability analyses of formulations

Why it matters

Knowing the right substance reached each animal at the right dose is what makes every result in the study mean something.

Practice: Practice: Test and reference items · 3 questions

Starts with the OECD distinction, in the Principles and consensus document number eight: an amendment is an intended change issued before the event, while a deviation is an unintended departure. Covers SOPs that are written, approved by management, available where the work is done and kept in a historical file, shown through the life of an SOP at RST from draft to retirement. Explains the written study plan verified by quality assurance and signed and dated by the Study Director before the study starts, with at least the content section 8.2 lists, and what RST's quality assurance found in the draft of 26-041. Shows the first amendment to study 26-041, and how deviations are described, explained, acknowledged and assessed. It ends with a recap and three practice questions.

What you will be able to do

• Write a study plan that contains what section 8.2 requires
• Tell a study plan amendment from a deviation
• Record a deviation with its explanation and assessment

Why it matters

Signing changes in advance and recording what really happened keeps a study's record honest and defensible.

Practice: Practice: SOPs, the study plan, amendments, deviations · 3 questions

Opens with OECD advisory document number twenty-two on data integrity: data that can be deleted, amended or excluded without authorisation or detection. Covers study conduct with a unique identification on every tube, slide, form and file for study 26-041, traceable specimens and following the plan. Explains recording raw data directly, promptly, accurately and legibly, signed and dated, with changes that never obscure the original and always carry a reason. Shows how RST mapped the data flows of 26-041, from paper clinical sign forms to checked transcriptions, kept old data readable before retiring a system, and reviewed its pathology audit trail before locking data. Covers validation, inventories, change control, IT security and data governance. In the exercise you review an audit trail extract and raw data. It ends with a recap, three practice questions and a practice exercise.

What you will be able to do

• Record and correct raw data so that it stays attributable
• Check that computerised systems are validated and change-controlled
• Review an audit trail by risk before data are locked

Why it matters

Data that show who did what, when and why are what lets a study survive inspection years later.

Practice: Practice: Study conduct, raw data and computerised systems · 3 questions

Starts with OECD advisory document number fifteen: raw data and specimens are the only means to reconstruct a study and verify its final report. Covers the final report with at least the content of section 9.2, signed by the Study Director only when complete, true and accurate, and corrected only by amendment. Shows the Ghent Principal Investigator sending the signed formulation analysis report on 28 August with written assurance and the Ghent QA statement, and how KLM's reviewer finding two transposed organ weights in the signed report leads to an amendment. Explains retaining the plan, raw data, samples, specimens and report, plus facility records, and an archive with a named archivist, secure conditions, an index, controlled access and a movement log. It ends with a recap and three practice questions.

What you will be able to do

• Check that a final report contains what section 9.2 requires
• Correct a signed final report by formal amendment
• Set up an archive with an archivist, index and movement log

Why it matters

A complete report and a well-kept archive mean anyone can rebuild and verify your study long after the team has moved on.

Practice: Practice: The final report, archives and retention · 3 questions

Opens with OECD position paper number twenty-one of May 2020 on the perception that sponsors may influence the conduct of GLP studies. Covers a multi-site study as one study, with one plan, one Study Director and one report, approved sites, chosen Principal Investigators and tested communication. Shows how RST moves formulation samples to the Ghent test site, labelled by study, group, date and type, packed with a temperature logger and a chain of custody form checked and signed on arrival. Explains how short-term, in vitro and field studies apply the same Principles with specific guidance. Shows RST handling KLM's comments on the draft report of 26-041, where the sponsor may comment but the Study Director decides the conclusions. It ends with a recap and three practice questions.

What you will be able to do

• Run a multi-site study as one study with one Study Director
• Apply the Principles to short-term, in vitro and field studies
• Handle sponsor comments without losing control of conclusions

Why it matters

Clear rules for sites and sponsors protect a study's conclusions from pressure, intended or not.

Practice: Practice: Special studies and sponsors · 3 questions

Returns to the Module 1 case through the monitoring system: in Germany, GLP monitoring rests on the national Chemicals Act and is carried out by the federal states. Covers how national GLP monitoring authorities inspect test facilities and audit studies, and how in the EU Member States designate them under Directive 2004/9/EC. Explains how an inspection and study audit run, the records inspectors ask for, and what can follow, from corrected minor deviations to statements of faults, recommendations to reject studies, removal from the programme or court action. Shows how RST hosts inspectors with a back room team and a log of every copy given, and a Rotterdam ecotoxicology laboratory's yearly mock inspection. In the exercise you prepare for an inspection and respond to three findings. It ends with a recap, three practice questions and a practice exercise.

What you will be able to do

• Explain how GLP monitoring authorities inspect and audit studies
• Prepare a facility to show its daily records at any time
• Respond to inspection findings by fixing the system

Why it matters

A facility ready every day, not tidied for an inspection, keeps its place in the monitoring programme.

Practice: Practice: Compliance monitoring: inspections, study audits · 3 questions

Opens with the question a monitoring authority asks in a study audit: can you follow one study from plan to archive? Shows study 26-041 on one screen in five stages: the plan verified by quality assurance and signed on 8 April, with the Ghent Principal Investigator signing for the analytical phase; preparation, with KLM-3 verified and rats isolated and checked; conduct, with formulations analysed in Ghent before dosing and raw data recorded directly; the report; and the archive. Traces one result back to the evidence that the high-dose group received its intended dose, works through a difficult month, revisits the opening case, and gives a short checklist the Study Director signs, a road map, and the final exam.

What you will be able to do

• Follow a GLP study through every stage from plan to archive
• Trace a reported result back to its raw data and records
• Apply the road map to your own facility's studies

Why it matters

Following one study end to end shows whether your evidence would satisfy a study audit in any OECD country.

Practice: Practice: Putting it together, and the exam · 3 questions