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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 ...
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 ...
A VMP is the foundation for the validation program and should include process validation, facility and utility qualification and validation, equipment qualification, cleaning and computer validation. It is a key document in the GMP ( Good manufacturing practice) regulated pharmaceutical industry as it drives a structured approach to validation ...
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]
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 ...
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.
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.
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.
Verification and validation. Verification and validation (also abbreviated as V&V) are independent procedures that are used together for checking that a product, service, or system meets requirements and specifications and that it fulfills its intended purpose. [1] These are critical components of a quality management system such as ISO 9000.
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