Good Laboratory Practise a necessity as number of Regulations and Guidelines constantly increase.

(PRWEB) December 21, 2003 --Research and Markets announces the addition of the Guide to Good Laboratory Practice to its offerings.

This guide is designed for Start-up and Growing Laboratories in Industry and Academia.

The time to market for a drug is critical in today's competitive market. Companies strive for speed and cost efficiencies in developing drugs for FDA approval. Keeping this in mind, each month spent in the laboratory is a month when the product is not earning revenue to pay back the ever-increasing costs of development and testing. This timeline is being extended due to stringent regulatory requirements, especially in the preclinical testing stages, where the principles of Good Laboratory Practices (GLP) play a major role.

In this guide you will find the most up-to-date information regarding the national & international regulations governing Good Laboratory Practice(GLP). Information on compliance with the ICH Common Technical Document format for reporting non-clinical laboratory results is also addressed.This is the most comprehensive and up-to-date Guide Good Laboratory Practice (GLP) on the market. The Guide includes copies of all the latest regulations and guidelines from the USA, ICH, and OECD, along with a customized set of audit forms for use by the laboratory QA Unit.

This report answers important questions such as How can my laboratory comply with GLP?, How can my laboratory improve upon specific areas of operation where compliance is most typically lacking?, What is the difference between GLP under the US 21CFR58 rules and the Principles of GLP from OECD?, How do I deal with Form 483 observations and warning letters concerning non-compliance with GLP? and how do I format my non-clinical study reports to comply with the new CTD requirements?

For a complete index of this report click on http://www.researchandmarkets.com/reports/41729

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