GLP covers the organizational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported.
The studies are intended to provide information about the properties or safety of products with respect to human health and the environment. The GLP requirements therefore apply to non-clinical safety studies and are linked to the regulatory requirements placed on this type of product.
Which products are covered?
Products that can be tested in GLP studies include:
- pharmaceuticals
- pesticides
- cosmetic products
- veterinary medicines
- food additives
- feed additives
- industrial chemicals
- medical devices
GLP is not a quality assurance system for laboratory operations in general. It is a study-based quality system intended to ensure the quality and reliability of non-clinical safety studies.
It differs from laboratory accreditation, which aims to ensure the quality of, for example, routine analyses.
The requirements and principles for GLP are established by the OECD (the Organisation for Economic Co-operation and Development).
Information for those who want to become GLP-approved
Do you want your laboratory to be included in Swedac’s GLP inspection programme? The guidance provides information on how to apply for GLP approval and which requirements apply.
Guidance for applying for GLP approval (swedac.se)
Information for those who test products
The requirements for Good Laboratory Practice (GLP) are set out in the OECD series of documents on GLP. The documents can be downloaded free of charge from the OECD website.
The GLP principles have also been incorporated into EU Directives 2004/9/EC and 2004/10/EC. The directives are available on EUR-Lex, the EU’s website for legislation and other legal documents.
GLP-approved laboratories
Here you can find Swedish laboratories that are GLP-approved and included in Swedac’s GLP inspection programme.
GLP Laboratories
GLP is to be used for non-clinical safety studies of products prior to registration and approval.
The following Swedish laboratories are GLP-approved:
| Laboratory | Working Area |
| ALS ScandinaviaAB | Analytical and Clinical Chemistry testing (8) |
| BioVet AB | Histopathology (9) |
| Hushållningssällskapet Skåne | Field residue studies (6) |
| Immuneed AB | In vitro studies (9) |
| Lablytica Life Science AB | Analytical and Clinical Chemistry testing (8) |
| Mercodia AB | Analytical and Clinical Chemistry testing (8) |
| National Veterinary Institute (SVA), Department of Chemistry | Analytical and Clinical Chemistry testing (8) |
| PKxpert AB | Toxicokinetic analysis studies (9) |
| RISE Research Institutes of Sweden AB, Medtech and Diagnostics | Cytotoxicity testing (2)In-vitro toxicity studies with cell systems and tissues (2) |
| RISE Research Institutes of Sweden AB, Chemical Process and Pharmaceutical Development, Chemical and Pharmaceutical Safety | Analytical and ClinicalChemistry testing (8) |
| Scantox Sweden AB, Adlego Biomedical | Toxicity studies (2) |
| Scantox Sweden AB, Q&Q Labs | Analytical and Clinical Chemistry testing (8) |
| SenzaGen AB, Medicon Village | In Vitro toxicity studies with cell systems (2), Cytotoxicity studies (2) |
| Svar Life Science AB | Analytical and Clinical Chemistry testing (8) |
| TATAA Biocenter AB | Molecular biology, qPCR, dPCR (9) |
Requirement and guidance documents
Approval according to GLP
Guidance for GLP compliance
SWEDAC DOC 00:5 | Swedac GLP Compliance Programme
Requirements for GLP
STAFS 2008:4 | Swedac’s regulations on the implementation of the OECD principles of Good Laboratory Practice (GLP)
STAFS 2013:12 | Regulations amending STAFS 2008:4 on the implementation of the OECD principles of Good Laboratory Practice (GLP)
STAFS 2014:11 | Regulations amending Swedac’s regulations (STAFS 2008:4) on the implementation of the OECD principles of Good Laboratory Practice (GLP)