Good Laboratory Practice

Good Laboratory Practice (GLP) is the OECD's quality system for non-clinical safety testing. The OECD describes the Principles of GLP as "a managerial quality control system covering the organisational process and the conditions under which non-clinical health and environmental studies are planned, performed, monitored, recorded and reported" (OECD GLP/MAD Q&A, 2015). GLP does not set the test method or the science. It governs how a test facility runs and documents a study, so that regulators can trust the data and audit it later.

Approach: I read the OECD GLP Q&A, the US FDA GLP rule (21 CFR Part 58), UK government GLP guidance, and the Polish and Swiss national GLP facility registers. I couldn't open the text of Directive 2004/10/EC on EUR-Lex this time, so the EU side below comes only from the Polish register's reference to it.

What the Principles cover (same OECD source)

• Who is responsible for what: test facility management, study personnel and quality assurance staff.
• Minimum standards for: suitable facilities and equipment, standard operating procedures, raw data documentation, study reports and record archiving.
• Traceability: inspectors can audit a study's results long after the study ended.
• Why it exists: in the 1970s some governments found that laboratories had submitted fraudulent studies to regulators.

Scope

• Studies: non-clinical tests in the laboratory, the greenhouse or the field. Studies on human subjects are excluded. Examples are physical-chemical tests, toxicity, mutagenicity, ecotoxicity, environmental fate and bioaccumulation, pesticide residues, mesocosm studies, and analytical and clinical chemistry.
• Products: pharmaceuticals, pesticides (including biocides), cosmetics, veterinary drugs, food additives, feed additives and industrial chemicals. Depending on the jurisdiction, medical devices may also be covered.

How compliance is checked and recognised

• Each country runs a national GLP Compliance Monitoring Programme. It inspects test facilities and audits studies, and a facility found compliant is recognised as GLP-compliant.
• Under the OECD Mutual Acceptance of Data (MAD) system, a study done to OECD Test Guidelines and GLP in one member or adhering country "must be accepted for assessment purposes" in all the others. The OECD sums this up as "tested once, accepted for assessment everywhere".

How it is written into law in each jurisdiction

Jurisdiction	Legal basis / monitoring
US (FDA)	21 CFR Part 58 "prescribes good laboratory practices for conducting nonclinical laboratory studies" supporting FDA applications for food and color additives, animal food additives, human and animal drugs, medical devices for human use, biological products and electronic products (21 CFR 58.1)
UK	Test facilities doing regulatory safety studies "must comply" with GLP and belong to the programme run by the UK GLP Monitoring Authority. The legal basis is SI 1999/3106 and SI 2004/994 (GOV.UK)
EU / Poland	The Polish GLP register is kept under the OECD Principles, Directive 2004/10/EC and the Polish Act on Chemical Substances [1]
Switzerland	The register lists facilities found compliant with the GLP Principles at the time of inspection, under the Ordinance on GLP (OGLP, SR 813.112.1) [2]

I can also look up whether a particular laboratory is on the Polish, Swiss, Japanese (FAMIC), Indian or Korean GLP facility registers.