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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 ...
Good manufacturing practice guidelines provide guidance for manufacturing, testing, and quality assurance in order to ensure that a manufactured product is safe for human consumption or use. Many countries have legislated that manufacturers follow GMP procedures and create their own GMP guidelines that correspond with their legislation.
Computerized system validation ( CSV) (Computeri s ed system validation in European countries, and usually referred to as "Computer Systems Validation") is the process of testing/validating/qualifying a regulated (e.g., US FDA 21 CFR Part 11 [1]) computerized system to ensure that it does exactly what it is designed to do in a consistent and ...
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]
When applicable, information as to whether the manufacturing site is periodically inspected by certifying authority and whether the manufacturing site complies with Good Manufacturing Practice (GMP) as recommended by WHO.
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 ...
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 ...
EudraGMP is the database of the European Community of manufacturing authorisations and of certificates of good manufacturing practice. The EudraGMP system was launched in April 2007, for use by European Medicines Regulators.
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 ⇌ {\displaystyle \rightleftharpoons } AMP + diphosphate + GMP + L -glutamate
In cryptography, a Schnorr signature is a digital signature produced by the Schnorr signature algorithm that was described by Claus Schnorr. It is a digital signature scheme known for its simplicity, among the first whose security is based on the intractability of certain discrete logarithm problems.