AVANCE Beginner's and GLP Guides

AVANCE Beginner's Guide

The goal of the AVANCE Beginner's Guide is to enable a relatively inexperienced user to carry out a series of basic 1-D High Resolution (HR) NMR experiments. Cholesterylacetate was chosen as an example. Both proton observe and carbon observe (with and without proton decoupling) are described. To assist the user standard parameter sets delivered with every XWIN-NMR software package will be used. However, rather than simply reading in standard parameter sets, a genuine effort has been made to help the user understand the relevance of the various parameters. In particular, this manual concentrates on describing the acquisition procedure, to some extent, at the expense of processing the acquired data. This emphasis minimizes the time spent on the actual spectrometer itself, particularly in the case where relatively large numbers of undergraduate students are being trained. In this scenario processing can be easily carried out on a separate workstation using the tutorials delivered with the spectrometer documentation.

While every effort has been made to genuinely provide a step-by-step description, new users will invariably have some questions, and as such will require occasional assistance from a more experienced user. The goal of this manual is, where practicable, to enable users to work independently and acquire a basic understanding of how to operate the system. It is hoped that the time taken to train new users will be significantly reduced with the use of this manual.

The manual is currently available in the following languages:

English

German

French

Spanish

Italian

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.