Good Laboratory Practice, GLP
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 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 USA, the basis of the GLP is CFR 21 Part 58.
GLP tests are classified into the following nine categories:
Studies required as part of the preclinical phase for marketing authorization process of new medicinal products have to be carried out in a GLP-certified laboratory. For Advances Therapy Medicinal Products (ATMPs), exceptions may be applicable 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.
The dataset to be obtained in the preclinical studies, as well as their duration are determined by ICH guidelines, which have been transferred into mandatory law by the European Commission. These include the ICH safety guidelines S1A, S1B, S1C(R2), S2(R1), and S6(R2), as well as multidisciplinary guidelines, such as ICH M3(R2).
The basic requirements and obligations of GLP are similar to those of GMP but differ in details and terminology. Hence, the principle of mutual recognition of GMP and GLP was favored for a long time, especially in the field of physical-chemical testing. Nevertheless, this has not prevailed.
Valicare offers you the following GLP services:
Valicare has a long-term experience in risk-based qualification of laboratory equipment, which helps you to meet your verification requirements. We offer advice regarding individual test methods, in particular for physical-chemical and in-vitro tests, especially under the 3R principles (Replace, Reduce, Refine/avoid animal testing). Furthermore, we are also pleased to support you in computer system validation.
Our expert auditors carry out audits at the laboratories you have contracted. We support your preparation for the inspection by conducting mock inspections, which enables identification of weak points in the quality management system. This allows you to eliminate these prior to the inspection by the supervisory authorities. We gladly train your employees with respect to inspection behavior.