GLP (Good Laboratory Practice)

GXP
This discussion addresses the need for analytical method validation in good laboratory practice (GLP) studies including stability studies Regulations clearly state that stability studies must be done and completed no later than the end of the GLP study. Responsibility for appropriateness of testing and completion of stability studies rests with test facility management. Stability of test mixtures containing active drugs with carriers is...

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GXP
Translational research involves bringing promising candidate drugs, biologics, and medical devices from the research bench into...Download
Article
Compliance in the manufacturing laboratory is a multi-faceted and often elusive goal. Alice Krumenaker, in her presentation...Download
GXP
ABSTRACT This article provides an overview of the US Food and Drug Administration’s good laboratory practice guidelines found...Download
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The employer provides training, the third component of the education, training, and experience mix. Based on the systems...Download
GXP
This paper has discusses the implications of the process hold times on microbial growth during pharmaceutical manufacturing. Microbiological risk exists -- especially with biological products. If microbial contamination occurs where microorganisms enter a product in sufficient numbers and if the process hold time is long enough, the process hold time may be problematic.
GXP
The following key points are discussed: Functions of the Institutional Animal Care and Use Committee (IACUC) in a good laboratory practice (GLP) animal testing facility are discussed. GLP regulations and United States Department of Agriculture regulations govern the handling of animals in research and testing.
GXP
There is confusion regarding the appropriate applications of good laboratory practice (GLP) regulations and good manufacturing practice (GMP) regulations, especially with regard to when they should be applied There may be a preference for working under GLP based on the belief that GLP regulations are less onerous and less costly than GMP The GMP definition of “manufacturing” includes testing...
GXP
The following key points are discussed: Basic good laboratory practice (GLP) quality system requirements include the use of equipment that is properly designed and maintained. Each GLP laboratory should have a comprehensive, up-to-date list of all equipment used in the facility including active and inactive equipment. Each GLP laboratory must establish a maintenance and calibration program...
GXP
Good laboratory practices (GLPs) have been universally recognized as rules that govern the conduct of non-clinical safety studies. The GLP goal is to ensure the quality, integrity, and reliability of the data developed from such studies, which in turn allows the appropriate assessment of the safety and effectiveness of the drug or device that is the object of the study. The US Food and Drug...

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