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Good documentation practice (recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained. While some GDocP standards are codified by various competent authorities, others ...
Similarly, The Rules Governing Medicinal Products in the European Union, Volume 4, Annex 11: Computerised Systems applies to all forms of computerized systems used as part of a GMP regulated activities and defines Computer System Validation Elements
A Validation Master Plan, also referred to as "VMP", outlines the principles involved in the qualification of a facility, defining the areas and systems to be validated, and provides a written program for achieving and maintaining a qualified facility. [1] A VMP is the foundation for the validation program and should include process validation ...
Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations that establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures (ERES). Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered ...
Current good manufacturing practices ( cGMP) are those conforming to the guidelines recommended by relevant agencies. Those agencies control the authorization and licensing of the manufacture and sale of food and beverages, [1] cosmetics, [2] pharmaceutical products, [3] dietary supplements, [4] and medical devices. [5]
The certificate of pharmaceutical product (abbreviated: CPP) is a certificate issued in the format recommended by the World Health Organization (WHO), which establishes the status of the pharmaceutical product and of the applicant for this certificate in the exporting country; [1] it is often mentioned in conjunction with the electronic Common ...
A gene signature or gene expression signature is a single or combined group of genes in a cell with a uniquely characteristic pattern of gene expression that occurs as a result of an altered or unaltered biological process or pathogenic medical condition.
Guanosine monophosphate (GMP), also known as 5′-guanidylic acid or guanylic acid (conjugate base guanylate), is a nucleotide that is used as a monomer in RNA. It is an ester of phosphoric acid with the nucleoside guanosine. GMP consists of the phosphate group, the pentose sugar ribose, and the nucleobase guanine; hence it is a ribonucleotide ...
GNU Multiple Precision Arithmetic Library (GMP) is a free library for arbitrary-precision arithmetic, operating on signed integers, rational numbers, and floating-point numbers. There are no practical limits to the precision except the ones implied by the available memory (operands may be of up to 2 32 −1 bits on 32-bit machines and 2 37 bits ...
In enzymology, a GMP synthetase (glutamine-hydrolysing) ( EC 6.3.5.2) is an enzyme that catalyzes the chemical reaction. ATP + xanthosine 5'-phosphate + L -glutamine + H 2 O AMP + diphosphate + GMP + L -glutamate. The 4 substrates of this enzyme are ATP, xanthosine 5'-phosphate, L -glutamine, and H 2 O, whereas its 4 products are AMP ...