Q.01

What does GLP certification mean for a testing laboratory?

GLP certification means a national GLP monitoring authority has inspected a test facility and confirmed that it runs its non-clinical safety studies under the OECD Principles of Good Laboratory Practice. The certificate covers how studies are planned, performed, recorded and reported. It does not say a test result is scientifically right. Its practical value is that regulators accept the facility's safety data, and in the EU an inspection result from one Member State is binding on the others.

What the law requires (EU)

  • Directive 2004/10/EC (the GLP principles): under Article 1, Member States must ensure that laboratories testing chemical products comply with GLP. The Directive cites Directive 67/548/EEC, which is the original dangerous-substances law. The obligation also applies wherever other EU rules require GLP for safety testing. Under Article 2, laboratories submitting results must certify that the tests were done in line with GLP. Annex I sets out the OECD Principles, which cover:
    • organisation and personnel
    • the quality assurance programme
    • facilities, apparatus and materials
    • test systems
    • documentation and archiving (EUR-Lex 32004L0010)
  • Directive 2004/9/EC (inspection and verification) is where the "certification" itself comes from:
    • Scope (Art. 1): GLP covers "the organisational processes and the conditions under which laboratory studies are planned, performed, recorded and reported" for non-clinical testing related to human health and the environment.
    • Inspecting authorities (Art. 3): Member States must designate authorities to inspect laboratories and audit studies.
    • Endorsement (Art. 2): a compliant laboratory can be endorsed with the formula "Assessment of conformity with GLP according to Directive 2004/9/EC on ... (date)".
    • Annual reporting (Art. 4): Member States report each year to the Commission which facilities they inspected and when.
    • Mutual recognition (Art. 5): inspection and audit results "shall be binding on the other Member States". If another Member State doubts a laboratory's compliance, Article 6 lets it ask for more information or a further audit. (EUR-Lex 32004L0009)

What a certification looks like in practice The Polish Bureau for Chemical Substances keeps its register under the OECD Principles, Directive 2004/10/EC and the Polish Act on Chemical Substances. Each entry shows the elements a GLP status is made of:

  • A certificate number: for example, the Warsaw University of Life Sciences holds 17/2024/DPL [1].
  • A defined area of expertise: certification covers specific study types, not the whole laboratory. Examples are "in vitro tests in the area of basal cytotoxicity" [1] and "6 (field phase)" [2].
  • Named test sites: these are listed alongside the main facility [2].
  • An ongoing inspection history: GLP status has to be kept up through repeat inspections. The National Institute of Horticultural Research's entry shows inspections from 08.2008 through 11.2025 [3].
  • Facilities outside Poland: the register also lists them. Jiangsu Limin Laboratory in Nanjing, China, has an entry, including an inspection marked "(remote control)" [4].
  • Removal: the register keeps a separate section for facilities taken off it [1].

What this means for you as a dossier owner

  • Check that the laboratory is on the relevant authority's GLP register at the time of the study.
  • Check that its listed area of expertise covers the study type, for example toxicity, analytical work or field trials.

Approach: I read the two GLP Directives on EUR-Lex and the Polish GLP register as a worked example. Swiss, Japanese, Indian and Korean GLP registers can also be searched if you need to check a specific laboratory. I couldn't open the OECD's own GLP page this time.

Q.02

How does Swiss GLP recognition work internationally?

Swiss GLP recognition works on three levels: the OECD Mutual Acceptance of Data (MAD) system; a GLP chapter in Switzerland's Mutual Recognition Agreement (MRA) with the EU, which now also exists with the UK; and bilateral memoranda of understanding with US, German and Japanese authorities. In every case the thing recognised is the Swiss monitoring programme and the GLP status it confers. Facilities do not get recognised one by one.

1. Domestic basis

  • The Chemicals Act (SR 813.1):
    • Art. 5(2)(a): the Federal Council "shall specify" the principles of GLP.
    • Art. 40(1): the Federal Council "may approve the recognition in particular of tests, inspections or assessments carried out abroad and of foreign reports or certificates".
    • Art. 40(3): federal authorities "shall cooperate" with foreign authorities and international organisations (Fedlex, ChemA).
  • The Ordinance on Good Laboratory Practice (OGLP, SR 813.112.1):
    • Annexes 1 and 2 reproduce OECD document No. 1 (the 1997 GLP Principles).
    • Under Art. 9, inspections and study audits "shall be carried out" according to Annex I, Sections A and B, of EU Directive 2004/9/EC. In practice Swiss inspections follow the EU inspection guidelines (Swiss GLP Compliance Monitoring Programme, v. EL02.10, 04.04.2024, §3.2).
  • The Swiss register confirms this basis. It is published by the Notification Authority for Chemicals on behalf of FOEN, FOPH and SECO under the OGLP, and lists facilities "inspected by the Swiss Monitoring Authorities and found to comply with the GLP Principles at the time of inspection". One example is Givaudan SA Ecotoxicology in Vernier, last inspected in June 2026, with areas ENF and PCT [5].

2. OECD MAD (multilateral)

  • Purpose: GLP-compliant results "are to be mutually accepted by the health and environment authorities of the OECD member states", so tests do not have to be repeated and fewer animal studies are needed (Programme, §1.1).
  • Peer review: Switzerland is subject to the OECD on-site evaluations of full MAD adherents. Its programme was evaluated in 2000 and 2014, and the document schedules the next one for 2024 (§7.3).
  • Reporting: the FOEN GLP unit is Switzerland's OECD coordination office. It reports inspections and facility status to the OECD and member states once a year, and reports non-compliant facilities or studies "immediately" (§7.2).
  • Requests from abroad: other MAD countries asking about a facility's status, or requesting a study audit, contact the Notification Authority. These requests follow OECD advisory document No. 12 or the MRA (§7.4).

3. EU-Switzerland MRA, Chapter 14 (in force 1 June 2002) Under the consolidated text on EUR-Lex (as at 22.12.2017):

  • Equivalence: the Parties "recognise the equivalence of each other's compliance monitoring programmes" that follow the OECD Council Acts C(81)30 and C(89)87.
  • Acceptance of data: the Parties "mutually accept studies and data generated therefrom", provided the test facility takes part in the other Party's GLP monitoring programme.
  • Acceptance of inspections: the Parties "mutually accept the conclusions of study audits and test facility inspections".
  • Origin: the Agreement's origin rule (Art. 4) does not apply to this chapter.
  • Scope: the EU legislation covered includes REACH, CLP, feed and food additives, GM food and feed, medicinal products for human and veterinary use, clinical trials, plant protection products, biocides, cosmetics, detergents and medical devices.
  • Safeguards:
    • The Parties exchange lists of compliant facilities at least once a year.
    • Either Party may request a further inspection or audit where there is "documented doubt".
    • In exceptional cases, either Party may send its own experts to join the other Party's inspection.
    • Either Party may observe the other's inspections, with the test facility's consent.
  • Source: EUR-Lex 02002A0430(05).

4. UK-Switzerland

  • The UK government says the UK and Switzerland have an MRA covering "good laboratory practice (GLP) of chemicals" (GOV.UK).
  • On 5 December the Federal Council extended the CH-UK mutual recognition agreement. GLP is one of three sectors moved into it from the trade agreement. The 2022 MRA was due to expire on 31 December 2025, and the page I opened gives no new end date (WBF).

5. Bilateral memoranda of understanding (Programme, §7.1) Switzerland has MoUs on mutual acceptance of its GLP programme with:

  • the US FDA
  • the US EPA
  • three German federal ministries (food and agriculture; youth, family, women and health; environment)
  • Japan's Ministry of Agriculture, Forestry and Fisheries
  • the Pharmaceutical Affairs Office of Japan's Ministry of Health and Welfare
  • Japan's Ministry of Health and Welfare together with its Ministry of International Trade and Industry

The programme document gives the history: after the 1976 FDA GLP rules, Swiss pharmaceuticals could not be exported to the USA. Article 271 of the Swiss Penal Code bars foreign authorities from inspecting in Switzerland, so Switzerland set up its own inspection system and a bilateral agreement instead (§1.2).

What reaches foreign authorities in practice (Programme, §5.6 and §5.9)

  • A facility found compliant gets a Statement of GLP Compliance. This is an English extract from the register, signed by the head of the Notification Authority.
  • Individual studies are "confirmed, but not certified".
  • There are three statuses: in compliance; not in compliance (the OECD "has been informed immediately"); and pending.
  • If a facility is removed, the FOEN unit notifies the OECD and its member states.

Approach: I searched the Swiss GLP test facilities register, which shows the legal basis but not the international arrangements. I then read the Swiss Chemicals Act on Fedlex, the Swiss GLP Compliance Monitoring Programme, the EU-Switzerland MRA on EUR-Lex, and the Swiss and UK government pages on the CH-UK agreement.

Q.03