Good Laboratory Practice (GLP)
GLP (Good Laboratory Practice) is to be used for non-clinical safety studies of products prior to registration and approval. The products tested are often synthetic chemical products, but may also be of natural or biological origin. The purpose of the studies is to produce information about their properties and/or safety as regards public health and/or the environment. The GLP requirement is thus only applicable to non-clinical safety studies and is connected to the regulatory requirements placed on this type of product.
GLP is a quality assurance system that covers the organisational process and the relations that prevail when non-clinical safety studies on humans and the environment are planned, carried out, supervised, and reported.
Products tested could be:
- Agrochemicals (pesticides/biocides)
- Industrial chemicals including detergents
- Human pharmaceuticals
- Veterinary pharmaceuticals
- Cosmetics
- Food/Feed additives
- Biochemical (antibody, peptide, protein, viral vector, enzyme)
- Living organism (cell, virus, microorganism)
- Medical devices
- Test items with complex composition
- Radiolabeled test items
It should be pointed out that GLP is not, generally speaking, a general quality assurance system for laboratory operations. GLP is a quality assurance system, the purpose of which is to ensure quality in non-clinical safety studies. It is study-based, while accreditation for laboratories aims at ensuring the quality of routine analyses.
The requirements and principles applicable to GLP are set by the OECD.
Swedac is a Swedish GLP authority, that is, the authority that tests and determines that laboratories meet GLP requirements and supervises these GLP laboratories.
GLP Laboratories
GLP is to be used for non-clinical safety studies of products prior to registration and approval.
These Swedish laboratories are GLP-approved:
| Laboratory | Working Area |
| ALS ScandinaviaAB | Analytical and Clinical Chemistry testing (8) |
| BioVet AB | Histopathology (9) |
| Carmeda AB | In vitro thrombogenicity (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) Toxicity studies (2) |
| PKxpert AB | Toxicokinetic analysis studies (9) |
| RISE Research Institutes of Sweden, Chemistry, Biomaterial and Textile | Cytotoxicity testing (2)In-vitro toxicity studies with cell systems and tissues (2) |
| RISE Research Institutes of Sweden, Chemical Process and Pharmaceutical Development, Chemical and Pharmaceutical Safety | Toxicity studies (2), 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) |
Documents for GLP requirements in Sweden
2004/9/EC, Directive of the European Parliament and of the council of 11 February 2004 on the inspection and verification of good laboratory practice (GLP)
2004/10/EC, Directive of the European Parliament of the council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances
OECD GLP no 1, OECD Series of principles of Good Laboratory Practice and compliance monitoring, No 1
STAFS 2008:4, Swedac´s regulations on the introduction of the OECD principles of Good Laboratory Practice (GLP)
Documents providing guidance for fulfilling GLP requirements in Sweden
SWEDAC DOC 00:5, Swedac GLP Compliance Programme
OECD GLP no 1, OECD Series of principles of Good Laboratory Practice and compliance monitoring, No 1