Regulated GxP Environments

14:51 Apr 20, 2005
This question was closed without grading. Reason: Other

English to Spanish translations [PRO]
IT (Information Technology)
English term or phrase: Regulated GxP Environments
Es una traducción sobre SAP. En el nombre de una publicación figura el término antes mencionado. "Good Practices for Computerized Systems in Regulated GxP Environments"
Valeria Vitale
Local time: 18:20

Summary of answers provided
4entornos con regulaciones de calidad (de la industria farmacéutica)
Leopoldo Gurman
3entornos reglamentados por GxP
Monica Lopez de Shinzato



9 mins   confidence: Answerer confidence 3/5Answerer confidence 3/5
regulated gxp environments
entornos reglamentados por GxP

Mirá esta info. Habría que tener un poco más de contexto.
Established in 1999 to offer cost effective engineering, production, computing and quality assurance services to the pharmaceutical and biotechnology industries, GxP has rapidly established itself as a trusted and high quality supplier to many blue chip companies.

GxP Ltd employs experienced personnel who work with you to deliver your products, engineering projects, computer systems and support services in the most cost effective manner whilst maintaining compliance with all the regulations and standards applicable to the pharmaceutical and biotechnology industries.

Monica Lopez de Shinzato
United States
Specializes in field
Native speaker of: Spanish
PRO pts in category: 22
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19 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5
regulated gxp environments
entornos con regulaciones de calidad (de la industria farmacéutica)

Esto es lo que encontré, los paréntesis por lo que agrega el segundo link, no todas los entornos regulados de este tipo son en empresas farmacéuticas. Saludos =:)

The term GxP is a generalization of quality guidelines, predominantly used in the pharmaceutical industry.* Good Manufacturing Practice, or GMP* Good Engineering Practice, or GEP* Good Laboratory Practice, or GLP* Good Safety Practice, or GSPGMP is the most commonly known instance of GxP. The term GxP is only used in a casual manner, to abstract from the actual set of quality guidelines.

Guidance for Inspectors
Pharmaceutical Inspection Convention Scheme (PIC/S)
Good Practices for Computerized Systems in Regulated "GxP" Envronments
The purpose of this document is to provide recommendations and background information concerning computerised systems that will be of assistance to inspectors for training purposes and during the inspection of computerised systems. The document will be of assistance to all ‘Good Practice’ Inspectors responsible for inspecting applications in the regulated pharmaceutical sector1; hence the use of the acronym ‘GxP’ in the title. It is recognised that not all companies subjected to GLP inspections are linked to the regulated pharmaceutical sector. However, it is considered that the guidance contained within this PIC/S document may also be beneficial to companies subjected to other regulatory frameworks and GLP inspection
The guidance document is intended to provide a logical explanation of the basic requirements for the implementation, validation and operation of computerised systems.
With 54 pages the guidance is very detailed. Specifically useful in preparation for inspections is a six page checklist.
Considered to be the primary GxP regulatory reference document for using computer computers.

Leopoldo Gurman
United States
Local time: 16:20
Works in field
Native speaker of: Spanish
PRO pts in category: 86
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