Quality management and GLP at the Central Animal Laboratory
The quality management system ensures that all the procedures are performed in accordance with internal and external quality assurance.
The personnel of the Central Animal Laboratory follows approved guidelines that comply with the quality management policy of the University of Turku. In addition, the Central Animal Laboratory follows the Good Laboratory Practice (GLP) guidelines of the OECD, which involves all the operations of the Laboratory, care taking of the animals, research, facility maintenance, documentation, archiving etc.
The Central Animal Laboratory ensures a high microbiological quality of the laboratory animals. Animals are acquired only from registered vendors with well-known microbiological status and the veterinarian at the CAL decides whether the animals are fit to enter the animal facilities or are sent to quarantine.
In special cases where the microbiological quality of animals is not known or the status is inadequate, the strain can be purified by embryo transfer or caesarean section.
A more comprehensive rodent health monitoring is done at least once a year and the general health monitoring approximately every 3–4 months following the FELASA's (Federation of European Animal Science Associations) recommendation guidelines for the health monitoring of mouse, rat, hamster, guinea pig and rabbit colonies in breeding and experimental units.
GLP – Good Laboratory Practice
GLP (Good Laboratory Practice) is a quality and documentation system of research required by the authorities in order to obtain the high quality and reliable test data related to the safety of industrial chemical substances and preparations in non-clinical studies. Due to the GLP status, it is mandatory that everybody who uses the facilities follows the GLP rules.
The OECD Guidelines for the testing of chemicals are followed in the Central Animal Laboratory to assess the safety of chemical products. The OECD principles are approved by GLP authorities as the most relevant internationally agreed testing methods.
According to GLP rules, all actions that take place in the Central Animal Laboratory (procedures in the facilities, documentation and archiving of activities) are described in details in SOPs (Standard Operating Procedure).
The facilities are routinely inspected by authorities from Finnish Medicines Agency (Fimea) according to the national GLP Compliance Monitoring Programme, approximately every second year or more often. The main reason is to ensure that the operating instructions are put into practice.
Central Animal Laboratory has been inspected in regular basis by GLP authorities and has received the Statement of Good Laboratory Practice Compliance in 2000, 2002, 2004, 2006, 2008, 2010, 2012, 2013, 2014, 2016 and 2018.
Test No. 402: Acute Dermal Toxicity
Test No. 404: Acute Dermal Irritation/Corrosion
Test No. 405: Acute Eye Irritation/Corrosion
Test No. 406: Skin Sensitisation
Test No. 407: Repeated Dose 28-dy Oral Toxicity Study in rodents
Test No. 408: Repeated Dose 90-day Oral Toxicity Study in rodents
Test No. 410: Repeated Dose Dermal Toxicity: 21/28-day Study
Test No. 411: Subchronic Dermal Toxicity: 90-day Study
Test No 414: Prenatal Developmental Toxicity Study
Test No. 417: Toxicokinetics
Test No. 420: Acute Oral Toxicity - Fixed Dose Procedure
Test No. 423: Acute Oral Toxicity - Acute Toxic Class Method
Test No. 425: Acute Oral Toxicity: Up-and-Down Procedure
Test No. 429: Skin Sensitisation: Local Lymph Node Assay
Test No. 452: Chronic Toxicity Studies