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.
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
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:
- General consulting
- Development or revision of your quality management system
- Generation of templates, e. g. test plans and reports
- On-site support for implementation
- Audits and mock inspections
- Applicability and exceptions for ATMPs (preparation of justifications for submission to authorities, ensuring complied measures)
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.