Good Laboratory Practice (GLP)

The Swedish government has designated Swedac as GLP authority in Sweden.

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
Adlego Biomedical AB Toxicity studies (2)
ALS Scandinavia AB Analytical Chemistry testing (8)
BioVet AB Histopathology (9)
Hushållningssällskapet Skåne Field residue studies (6)
Karolinska Universitetssjukhuset, Klinisk farmakologi Analytical and Clinical Chemistry testing (8)
Mercodia AB Analytical Chemistry testing (8)
National Veterinary Institute (SVA)
Department of Chemistry, Environment and Feed Hygiene
Analytical and Clinical Chemistry testing (8)
PKexpert AB Toxicokinetic analysis studies (9)
Q&Q Labs AB Analytical and Clinical Chemistry testing (8)
Recipharm OT Chemistry AB Analytical and Clinical Chemistry (8)
RISE Research Institutes of Sweden, Bioscience and Materials, Medical Device Technology Cytotoxicity testing (2) In-vitro toxicity studies with cell systems and tissues (2)
RISE Research Institutes of Sweden AB, Surface, Process and Formulation Analytical and Clinical Chemistry testing (8)
RISE Research Institutes of Sweden, Bioscience and Materials, Chemical & Pharmaceutical Safety Toxicity studies (2), Analytical Chemistry testing (8)
Toxicon AB Ecotoxicity studies (2)
Veolia Water Technologies AB Physical-chemical testing (1), bio tests (9)
Vironova Biosafety AB Validation studies for virus removal / inactivation (9)
Wieslab AB Analytical and Clinical Chemistry testing (8)

 

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