Over 35 years of good laboratory practice (GLP) in Germany A successful history of quality assurance
What it's about:
Good Laboratory Practice (GLP) is a quality system concerned with the organisational process and the conditions under which non-clinical health and environmental safety studies are planned, performed and monitored. It also sets out requirements for the recording, archiving and reporting of GLP studies. It was developed to ensure the quality, integrity and traceability of study data and to strengthen confidence in the results of regulatory safety studies
The adoption of the OECD GLP Principles in over 40 countries to date and the mutual acceptance of data generated in accordance with them have made GLP a key instrument of quality assurance in health and environmental protection. The international acceptance of study data thus avoids unnecessary duplicate testing whilst also contributing to the conservation of resources and the reduction of animal testing. Germany, which voluntarily adopted the OECD GLP principles in 1983 and incorporated them into law in 1990, has since gained extensive experience in monitoring compliance with these principles within the country.
To mark the 35th anniversary of the incorporation of GLP in German law, the German Federal Institute for Risk Assessment (BfRshort forGerman Federal Institute for Risk Assessment) has published a report on the German GLP compliance monitoring programme:
The publication traces the development of the German GLP compliance monitoring programme from its beginnings to the present day, describes key milestones and acknowledges the close cooperation between the regulatory authorities of the German federal states and the GLP Federal Bureau at the BfRshort forGerman Federal Institute for Risk Assessment.
GLP was formed in the 1970s, partly in response to serious deficiencies and, in some cases, fraudulent practices in the conduct of pre-clinical safety tests in the USA. The regulatory standards developed as a result were later adopted by the OECD and now form the basis of the system of mutual acceptance of data (MAD). Germany has one of the largest and most established GLP compliance monitoring programmes since its introduction in August 1990: almost 2,000 inspections have been carried out since then, and German test facilities cover all the areas of expertise defined by the OECD guidelines. Today, the German GLP compliance monitoring programme comprises 143 national and three international test facilities, which are inspected by the 16 monitoring authorities of the German federal states and the GLP Federal Bureau at the BfRshort forGerman Federal Institute for Risk Assessment.
Weitere Informationen auf der BfRshort forGerman Federal Institute for Risk Assessment-Website zur GLP
- Tasks of the GLP Federal Bureau Go to page
- BfRshort forGerman Federal Institute for Risk Assessment communication: Cooperation to strengthen good laboratory practice (GLP) Go to Communication