Comprehensive services for GLP compliance and implementation

GLP stands for Good Laboratory Practice and defines principles for the non-clinical and environmental safety study of substances or preparations and is not to be mistaken for the requirements of quality control under GMP and GCP.

Guidelines and laws

In Europe, directives 2004/9/EC and 2004/10/EC form the basis of the requirements for GLP. These directives had to be implemented into national law by the member states. Therefore, Germany published the Chemicals Act Annex 1 contained therein. However, the European Union itself did not develop requirements on its own. The concept was established by the OECD and complies with ENV/MC/CHEM(98)17. Accordingly, detailed information can also be obtained from the OECD. In the U.S., CFR 21 Part 58 is the basis for GLP.

GLP tests are classified into the following nine categories:

• Physical-chemical testing
• Toxicity studies
• Mutagenicity studies
• Environmental toxicity studies on aquatic and terrestrial organisms

• Studies on behavior in water, soil and air; bioaccumulation
• Residue studies
• Studies on effects on mesocosms and natural ecosystems
• Analytical and clinical chemistry testing

• Other studies

GLP requirements for the preclinical phase

Studies required as part of the preclinical phase for the marketing authorization process of new medicinal products must be carried out in a GLP-certified laboratory. Exceptions may be applicable for Advanced Therapy Medicinal Products (ATMPs) due to their special characteristics, as described by the EMA and the ICH. A non-application of the GLP regulations must be justified on a case-by-case basis. In addition, GLP regulations are applicable to the safety assessment of chemicals, as for instance required for REACH. 

ICH guidelines determine the dataset to be obtained in preclinical studies, as well as their duration. These guidelines have been transferred into mandatory law by the European Commission. They include the ICH safety guidelines S1A, S1B, S1C(R2), S2(R1), and S6(R2), as well as multidisciplinary guidelines, such as ICH M3(R2).