Search results
Results from the Go Local Guru Content Network
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 ...
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]
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
This is a list of file signatures, data used to identify or verify the content of a file. Such signatures are also known as magic numbers or Magic Bytes. Many file formats are not intended to be read as text. If such a file is accidentally viewed as a text file, its contents will be unintelligible. However, some file signatures can be ...
Good automated manufacturing practice ( GAMP) is both a technical subcommittee of the International Society for Pharmaceutical Engineering (ISPE) and a set of guidelines for manufacturers and users of automated systems in the pharmaceutical industry. [1] More specifically, the ISPE's guide The Good Automated Manufacturing Practice (GAMP) Guide ...
The time signature indicates the meter of a musical movement at the bar level. In a music score the time signature appears as two stacked numerals, such as 4. 4 (spoken as four–four time ), or a time symbol, such as (spoken as common time ). It immediately follows the key signature (or if there is no key signature, the clef symbol).
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 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 ...
The database serves as a quick reference for checking the good manufacturing practice (GMP) of a potential contract manufacturer. One can search by the “company name, location, or certificate number and find details on the types of products or activities that the company conducts and the date of the most recent GMP inspection.”
In enzymology, a GMP synthetase (glutamine-hydrolysing) ( EC 6.3.5.2) is an enzyme that catalyzes the chemical reaction. The 4 substrates of this enzyme are ATP, xanthosine 5'-phosphate, L -glutamine, and H 2 O, whereas its 4 products are AMP, diphosphate, GMP, and L -glutamate . This enzyme belongs to the family of ligases, specifically those ...