science

Good laboratory practice

Good laboratory practice is a science topic covered in the lgStudy science library. This page brings together a partial reference excerpt, illustrations, worked examples, real-world applications and a short study plan, so you can understand Good laboratory practice rather than just read about it. In short: The Principles of Good Laboratory Practice (GLP) establish rules and criteria for a quality system that oversees the organizational processes and conditions in which non-clinical (non-pharmaceutical) health and environmental safety–or simply toxicology–studies are planned, conducted, monitored, recorded, reported, and archived. These principles apply to the toxicity testing of chemicals in commerce, to ensure the qu…

Key takeaways

Good laboratory practice belongs to science; place it in that map before memorising details.
Learn the definition first, then one example that makes the definition concrete.
Connect Good laboratory practice to a quantity you can measure, compute or draw — that is where exam questions come from.
Reproduce the core statement of Good laboratory practice from memory before moving on to harder problems.

Reference excerpt

The Principles of Good Laboratory Practice (GLP) establish rules and criteria for a quality system that oversees the organizational processes and conditions in which non-clinical (non-pharmaceutical) health and environmental safety–or simply toxicology–studies are planned, conducted, monitored, recorded, reported, and archived. These principles apply to the toxicity testing of chemicals in commerce, to ensure the quality and integrity of the safety data submitted by manufacturers to regulatory authorities globally.

History The historical events leading to the proposal of the Good Laboratory Practice (GLP) regulations are crucial for understanding why these regulations are important to improve the quality and integrity of chemical safety data. They were developed in response to concerns about the reliability of toxicity data from industry. The GLP regulations aim to standardize procedures and practices to ensure accurate, reliable, and traceable safety data. GLP was first introduced in New Zealand and Denmark in 1972, but only as quality standards for re-agents and lab materials (first created in Australia due to being isolated from western labs by the Japanese blockade of WW2); the US FDA heard about them from NZ at an international conference just as the below IBT scandal broke). During the 1960s and 1970s, a growing concern for environmental issues and health impacts of chemicals was one factor in increased federal regulation, particularly in the chemical and pharmaceutical sectors, leading to more stringent product testing requirements and the development of inspection programs targeting laboratories conducting animal research in developed countries. These initiatives, initiated in the US by the Office of New Drugs and the Office of Marketed Drugs in 1969 and later expanded with the Office of Compliance, included inspections of facilities with questionable study validity or misconduct tips, revealing significant quality control issues and deficiencies in animal toxicological testing standards and data reporting. Industrial BioTest Labs (IBT) was the most notable whistleblower case where thousands of safety tests for chemical manufacturers were either falsely claimed to have been performed or were of such poor quality that police investigators could not determine the extent of the work completed, despite superficially delivering test results as specified in their contracts with the manufacturers. IBT, a contract laboratory based in Northbrook, Illinois, conducted research for the United States government and various chemical and pharmaceutical companies, both from the U.S. and abroad, and submitted toxicology data to several federal agencies, covering a wide range of products including drugs, insecticides, herbicides, food additives, pesticides, cosmetics, and cleaning products. These issues were aired in hearings at the US Congress, which pressured the FDA to propose draft Regulations on GLP on November 19, 1976, and establishment of the Final Rule in June 1979 which became effective on June 20, 1979. Proposed amendments were introduced on October 29, 1984. The GLP amendment Final Rule was published on September 4, 1987 and became effective on October 5, 1987. Many of the fraudulent safety data concerned chemicals overseen by the new Environmental Protection Agency (EPA), so their GLP rule was developed simultaneously with FDA, the EPA issuing its draft GLP regulations in 1979 and 1980, publishing the Final Rules in two separate parts (40 CFR 160 and 40 CFR 792) in 1983. GLP requires not only that the methods of safety tests be transparent, but that they be so detailed that a different laboratory using it will get the same result. Considering that Japan, Netherlands, US and others had at same time as GLP begun requiring demonstrations of safety before chemicals gained access markets; the Organisation for Economic Cooperation & Development decided that multinational companies needed globally uniform regulation of chemicals, such that a toxicity test performed in one country could be accepted by another. OECD was thus happy to add the new USA GLP requirement into their new, globally-required test methods, called ‘OECD Test Guidelines’ (see below OECD section).

… excerpt ends here. Continue reading the full article.

Worked examples

Example 1 — a first encounter with Good laboratory practice

Start with the simplest possible case. Write down what Good laboratory practice claims or describes in one sentence, then invent the smallest concrete situation in which that sentence is true. In science, the smallest case is usually a single object, a single equation or a single measurement. Check that every symbol or term in your sentence has a meaning in that case.

Example 2 — changing one variable

Take the situation from Example 1 and change exactly one quantity: double it, halve it, or set it to zero. Predict what should happen to Good laboratory practice before you calculate. Comparing your prediction with the result is the fastest way to find out whether you understand the idea or only the words.

Example 3 — an exam-style question

Typical questions about Good laboratory practice ask you to (a) state it precisely, (b) apply it to given data, and (c) explain a limitation. Practise writing all three answers in under five minutes; the third part is what separates a full-mark answer from an average one.

Applications of Good laboratory practice

In research: Good laboratory practice appears in science research whenever the underlying quantities have to be modelled precisely. Papers usually cite it as a starting assumption and then explore where it breaks down.
In technology and industry: Engineering practice reuses Good laboratory practice in design rules, simulations and safety margins. Knowing the idea lets you read a specification sheet and understand why the numbers look the way they do.
In the classroom: Good laboratory practice is common in secondary-school and first-year university syllabi. It links to neighbouring topics Good practice, Laboratories, OECD, so understanding it makes those chapters shorter.
In everyday life: Look for Good laboratory practice outside the textbook — in sport, cooking, traffic, electronics or the sky above you. An example you found yourself is remembered far longer than one you were given.

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How to study Good laboratory practice in 20 minutes

Read the reference excerpt below once, without taking notes.
Close the page and write down what Good laboratory practice means in your own words.
Compare your version with the excerpt and mark what you missed.
Work through the three examples above with pen and paper.
Explain Good laboratory practice out loud to somebody else — or to Teacher Smith in the lgStudy chat.

Frequently asked questions

What is Good laboratory practice in simple terms?

Why does Good laboratory practice matter?

Because it connects several science ideas at once: it gives you a definition you can apply, a quantity you can calculate, and a way to check whether a result is plausible.

How should I study Good laboratory practice?

Read the excerpt, restate it from memory, then work through the examples and applications listed on this page. The five-step study plan above takes about twenty minutes.

What does this page cover?

It gives you a compact reference excerpt plus original lgStudy explanations, examples, applications and study material on Good laboratory practice.