GLP Verification User Guide
Many chemical, pharmaceutical, biotech companies and laboratories must comply with regulatory requirements or are planning to organize their activity according to federal or international quality management standards. One of the best known standards is GLP, or Good Laboratory Practice.
In the U.S.A. GLP documents are issued by the Food and Drug Administration (FDA). The FDA GLP regulations are enforceable under the Federal Food, Drug and Cosmetic Act, and apply to non-clinical laboratory studies that are submitted to the FDA in support of an application for a research or marketing permit.
FDA regulations have also been taken on by the Council of the OECD countries, who then advised the corresponding health ministers to adopt GLP. Laws have then been formulated to cover this matter in each country, i.e., to regulate the way chemical substances are dealt with and with instrumentation in non-clinical laboratories.
Based on its official definition, GLP is concerned with the organizational processes and conditions under which laboratory studies are:
Planned
Performed
Monitored
Recorded
Reported
GLP data are intended to promote the quality and validity of test data.
The GLP Requirements User Guide provides an overview of GLP for laboratory managers (LM’s), and those people responsible in applying GLP principles to the above mentioned conditions in an environment with NMR systems.