Difference between revisions of "Template:Article of the week"

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<div style="float: left; margin: 0.5em 0.9em 0.4em 0em;">[[File:Dialysis machines by irvin calicut.jpg|250px]]</div>
<div style="float: left; margin: 0.5em 0.9em 0.4em 0em;">[[File:Pharma-production.jpg|200px]]</div>
An '''[[end-stage renal disease facility]]''' ('''ESRD facility''', '''dialysis facility''', or '''dialysis center''') is a medical facility that operates to assist people with irreversible loss of kidney function (stage five), requiring a regular course of dialysis or a kidney transplant to survive. The facility may operate independently, as part of a [[hospital]]-based unit, or as a self-care unit that furnishes only self-dialysis services.
'''[[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. One of the core principles of GAMP is that quality cannot be tested into a batch of product but must be built into each stage of the manufacturing process. As a result, GAMP covers all aspects of production; from the raw materials, facility and equipment to the training and hygiene of staff.


The U.S. [[Centers for Medicare and Medicaid Services]] (CMS) describes four types of ESRD facilities, including the renal transplantation center, for ESRD transplant patients; the renal dialysis center, a hospital unit for ESRD dialysis patients; a renal dialysis facility, a direct or stand-alone dialysis unit for ESRD patients; and a self-dialysis unit attached to one of the previous three, providing self-dialysis services. Patients undergoing dialysis at these facilities require two important documentation steps: the patient assessment and the patient plan of care. U.S. Federal regulation requires a comprehensive 13-point assessment, including current health status, laboratory profile, and nutritional status. ('''[[End-stage renal disease facility|Full article...]]''')<br />
GAMP is largely about automated system validation. In October 2014, Irish tech company Dataworks Ltd. described it as such:
 
<blockquote>It is a formal process of thorough documentation, testing, and logical process steps that validate clients' required specifications. The process begins with a user requirements specification for the machine, from which a functional requirement and a design specification are created. These documents then form the basis for the traceability matrix and for the formal testing of internal acceptance, factory acceptance, and site acceptance. Categorising software is used to support the approach to validation based on the difficulty and individuality of the computerised system.</blockquote>
 
('''[[Good Automated Manufacturing Practice|Full article...]]''')<br />
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''Recently featured'': [[Genome informatics]], [[Cancer informatics]], [[Evolutionary informatics]]
''Recently featured'': [[End-stage renal disease facility]], [[Genome informatics]], [[Cancer informatics]]

Revision as of 17:45, 17 February 2015

Pharma-production.jpg

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. One of the core principles of GAMP is that quality cannot be tested into a batch of product but must be built into each stage of the manufacturing process. As a result, GAMP covers all aspects of production; from the raw materials, facility and equipment to the training and hygiene of staff.

GAMP is largely about automated system validation. In October 2014, Irish tech company Dataworks Ltd. described it as such:

It is a formal process of thorough documentation, testing, and logical process steps that validate clients' required specifications. The process begins with a user requirements specification for the machine, from which a functional requirement and a design specification are created. These documents then form the basis for the traceability matrix and for the formal testing of internal acceptance, factory acceptance, and site acceptance. Categorising software is used to support the approach to validation based on the difficulty and individuality of the computerised system.

(Full article...)

Recently featured: End-stage renal disease facility, Genome informatics, Cancer informatics

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