Valicare offers comprehensive services to help you achieving GLP compliance
GLP stands for Good Laboratory Practice and defines principles for the non-clinical and environmental safety study of substances or preparations. GLP has to be distinguished from the requirements of quality control under GMP and GCP.
In Europe, directives 2004/9/EC and 2004/10/EC are 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. 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 USA, the basis of GLP is given in 21 CFR part 58.
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