Good Automated Laboratory Practices - Revision history

Shawndouglas: Updated URLs for 2022

2022-01-07T22:39:00Z

Updated URLs for 2022

← Older revision		Revision as of 22:39, 7 January 2022
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	The '''Good Automated Laboratory Practices''' ('''GALP''') was a [[United States Environmental Protection Agency\|U.S. EPA-based]] conglomeration of "regulations, policies, and guidance documents establishing a uniform set of procedures to ensure the reliability and credibility of [[laboratory]] data."<ref name="LIMSPaszko">{{cite book \|author=Paszko, Christine; Paszko Turner; Elizabeth Turner \|title=Laboratory Information Management Systems \|chapter=Chapter 6: Regulatory Requirements \|year=2001 \|pages=59 \|publisher=CRC Press \|url=~~http~~://books.google.com/books?id=ycEqnzPl2lYC \|isbn=0824741412}}</ref> GALP is considered an expired policy by the EPA, though the true expiration date is not know.<ref name="EPAExpired">{{cite web \|url=http://www.epa.gov/irmpoli8/expiredpolicies/index.html \|archiveurl=https://web.archive.org/web/20150401070540/http://www.epa.gov/irmpoli8/expiredpolicies/index.html \|title=Expired Policies/Directives - Office of Environmental Information - US EPA \|publisher=U.S. EPA \|archivedate=01 April 2015 \|accessdate=15 April 2020}}</ref>		The '''Good Automated Laboratory Practices''' ('''GALP''') was a [[United States Environmental Protection Agency\|U.S. EPA-based]] conglomeration of "regulations, policies, and guidance documents establishing a uniform set of procedures to ensure the reliability and credibility of [[laboratory]] data."<ref name="LIMSPaszko">{{cite book \|author=Paszko, Christine; Paszko Turner; Elizabeth Turner \|title=Laboratory Information Management Systems \|chapter=Chapter 6: Regulatory Requirements \|year=2001 \|pages=59 \|publisher=CRC Press \|url=https://books.google.com/books?id=ycEqnzPl2lYC \|isbn=0824741412}}</ref> GALP is considered an expired policy by the EPA, though the true expiration date is not know.<ref name="EPAExpired">{{cite web \|url=http://www.epa.gov/irmpoli8/expiredpolicies/index.html \|archiveurl=https://web.archive.org/web/20150401070540/http://www.epa.gov/irmpoli8/expiredpolicies/index.html \|title=Expired Policies/Directives - Office of Environmental Information - US EPA \|publisher=U.S. EPA \|archivedate=01 April 2015 \|accessdate=15 April 2020}}</ref>

	==History==		==History==

	Work on GALP was first started by the EPA in 1989 as an extension of its pre-existing good laboratory practice (GLP) requirements to what they saw as a state of increasing automation in laboratories.<ref name="GALPBook1">{{cite book \|author=Weinberg, Spelton & Sax, Inc. \|title=GALP Regulatory Handbook \|chapter=Chapter 1: Why GALPs??? \|year=1994 \|pages=2–4 \|publisher=CRC Press \|url=~~http~~://books.google.com/books?id=RfzlSKm581EC \|isbn=1566700256}}</ref> An additional revision was released in 1995 by the EPA.<ref name="EPAGALP">{{cite web \|url=http://www.epa.gov/irmpoli8/expiredpolicies/2185.pdf \|archiveurl=https://web.archive.org/web/20131021091515/http://www.epa.gov/irmpoli8/expiredpolicies/2185.pdf \|format=PDF \|title=EPA 2185 - Good Automated Laboratory Practices - Principles and Guidance to Regulations for Ensuring Data Integrity in Automated Laboratory Operations \|author=U.S. Environmental Protection Agency \|publisher=U.S. Environmental Protection Agency \|date=10 August 1995 \|archivedate=21 October 2013}}</ref>		Work on GALP was first started by the EPA in 1989 as an extension of its pre-existing good laboratory practice (GLP) requirements to what they saw as a state of increasing automation in laboratories.<ref name="GALPBook1">{{cite book \|author=Weinberg, Spelton & Sax, Inc. \|title=GALP Regulatory Handbook \|chapter=Chapter 1: Why GALPs??? \|year=1994 \|pages=2–4 \|publisher=CRC Press \|url=https://books.google.com/books?id=RfzlSKm581EC \|isbn=1566700256}}</ref> An additional revision was released in 1995 by the EPA.<ref name="EPAGALP">{{cite web \|url=http://www.epa.gov/irmpoli8/expiredpolicies/2185.pdf \|archiveurl=https://web.archive.org/web/20131021091515/http://www.epa.gov/irmpoli8/expiredpolicies/2185.pdf \|format=PDF \|title=EPA 2185 - Good Automated Laboratory Practices - Principles and Guidance to Regulations for Ensuring Data Integrity in Automated Laboratory Operations \|author=U.S. Environmental Protection Agency \|publisher=U.S. Environmental Protection Agency \|date=10 August 1995 \|archivedate=21 October 2013}}</ref>

	The GALP's creation was based on six principles<ref name="GALPBook2">{{cite book \|author=Weinberg, Spelton & Sax, Inc. \|title=GALP Regulatory Handbook \|chapter=Chapter 1: Why GALPs??? \|year=1994 \|pages=8–9 \|publisher=CRC Press \|url=~~http~~://books.google.com/books?id=RfzlSKm581EC \|isbn=1566700256}}</ref>:		The GALP's creation was based on six principles<ref name="GALPBook2">{{cite book \|author=Weinberg, Spelton & Sax, Inc. \|title=GALP Regulatory Handbook \|chapter=Chapter 1: Why GALPs??? \|year=1994 \|pages=8–9 \|publisher=CRC Press \|url=https://books.google.com/books?id=RfzlSKm581EC \|isbn=1566700256}}</ref>:

	1. The system must provide a method of assuring the integrity of all entered data.		1. The system must provide a method of assuring the integrity of all entered data.
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	==Further reading==		==Further reading==
	* {{cite web \|url=http://www.epa.gov/irmpoli8/expiredpolicies/2185.pdf \|archiveurl=https://web.archive.org/web/20131021091515/http://www.epa.gov/irmpoli8/expiredpolicies/2185.pdf \|format=PDF \|title=EPA 2185 - Good Automated Laboratory Practices - Principles and Guidance to Regulations for Ensuring Data Integrity in Automated Laboratory Operations \|author=U.S. Environmental Protection Agency \|publisher=U.S. Environmental Protection Agency \|date=10 August 1995 \|archivedate=21 October 2013}}		* {{cite web \|url=http://www.epa.gov/irmpoli8/expiredpolicies/2185.pdf \|archiveurl=https://web.archive.org/web/20131021091515/http://www.epa.gov/irmpoli8/expiredpolicies/2185.pdf \|format=PDF \|title=EPA 2185 - Good Automated Laboratory Practices - Principles and Guidance to Regulations for Ensuring Data Integrity in Automated Laboratory Operations \|author=U.S. Environmental Protection Agency \|publisher=U.S. Environmental Protection Agency \|date=10 August 1995 \|archivedate=21 October 2013}}

	==References==		==References==
	~~<references />~~		{{Reflist\|colwidth=30em}}

	<!---Place all category tags here-->		<!---Place all category tags here-->
	[[Category:Regulatory information]]		[[Category:Regulatory information]]

Shawndouglas: Updated citations for 2020.

2020-04-15T20:30:28Z

Updated citations for 2020.

← Older revision		Revision as of 20:30, 15 April 2020
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	The '''Good Automated Laboratory Practices''' ('''GALP''') was a [[United States Environmental Protection Agency\|U.S. EPA-based]] conglomeration of "regulations, policies, and guidance documents establishing a uniform set of procedures to ensure the reliability and credibility of [[laboratory]] data."<ref name=LIMSPaszko>{{cite book \|author=Paszko, Christine; Paszko Turner; Elizabeth Turner \|title=Laboratory Information Management Systems \|chapter=Chapter 6: Regulatory Requirements \|year=2001 \|pages=59 \|publisher=CRC Press \|url=http://books.google.com/books?id=ycEqnzPl2lYC \|isbn=0824741412}}</ref> GALP is considered an expired policy by the EPA, though the true expiration date is not know.<ref>{{cite web \|url=http://www.epa.gov/irmpoli8/expiredpolicies/index.html \|title=Expired Policies/Directives - Office of Environmental Information - US EPA \|publisher=U.S. EPA \|accessdate=~~28 February 2012~~}}</ref>		The '''Good Automated Laboratory Practices''' ('''GALP''') was a [[United States Environmental Protection Agency\|U.S. EPA-based]] conglomeration of "regulations, policies, and guidance documents establishing a uniform set of procedures to ensure the reliability and credibility of [[laboratory]] data."<ref name="LIMSPaszko">{{cite book \|author=Paszko, Christine; Paszko Turner; Elizabeth Turner \|title=Laboratory Information Management Systems \|chapter=Chapter 6: Regulatory Requirements \|year=2001 \|pages=59 \|publisher=CRC Press \|url=http://books.google.com/books?id=ycEqnzPl2lYC \|isbn=0824741412}}</ref> GALP is considered an expired policy by the EPA, though the true expiration date is not know.<ref name="EPAExpired">{{cite web \|url=http://www.epa.gov/irmpoli8/expiredpolicies/index.html \|archiveurl=https://web.archive.org/web/20150401070540/http://www.epa.gov/irmpoli8/expiredpolicies/index.html \|title=Expired Policies/Directives - Office of Environmental Information - US EPA \|publisher=U.S. EPA \|archivedate=01 April 2015 \|accessdate=15 April 2020}}</ref>

	==History==		==History==

	Work on GALP was first started by the EPA in 1989 as an extension of its pre-existing [[good laboratory practice]] (GLP) requirements to what they saw as a state of increasing automation in laboratories.<ref name=GALPBook1>{{cite book \|author=Weinberg, Spelton & Sax, Inc. \|title=GALP Regulatory Handbook \|chapter=Chapter 1: Why GALPs??? \|year=1994 \|pages=2–4 \|publisher=CRC Press \|url=http://books.google.com/books?id=RfzlSKm581EC \|isbn=1566700256}}</ref> An additional revision was released in 1995 by the EPA.<ref name=EPAGALP>{{cite web \|~~last~~=~~[[United States Environmental Protection Agency]]~~ \|title=Good Automated Laboratory Practices - Principles and Guidance to Regulations for Ensuring Data Integrity in Automated Laboratory Operations \|~~url~~=~~http://cfpub~~.~~epa~~.~~gov/ols/catalog/catalog_display.cfm?&FIELD1=SUBJECT&INPUT1=Automation&TYPE1=EXACT&item_count=45~~ \|publisher=U.S. ~~EPA, Office of Information Resources Management~~ \|date=1995 \|~~accessdate~~=~~25 February 2012~~}}</ref>		Work on GALP was first started by the EPA in 1989 as an extension of its pre-existing good laboratory practice (GLP) requirements to what they saw as a state of increasing automation in laboratories.<ref name="GALPBook1">{{cite book \|author=Weinberg, Spelton & Sax, Inc. \|title=GALP Regulatory Handbook \|chapter=Chapter 1: Why GALPs??? \|year=1994 \|pages=2–4 \|publisher=CRC Press \|url=http://books.google.com/books?id=RfzlSKm581EC \|isbn=1566700256}}</ref> An additional revision was released in 1995 by the EPA.<ref name="EPAGALP">{{cite web \|url=http://www.epa.gov/irmpoli8/expiredpolicies/2185.pdf \|archiveurl=https://web.archive.org/web/20131021091515/http://www.epa.gov/irmpoli8/expiredpolicies/2185.pdf \|format=PDF \|title=EPA 2185 - Good Automated Laboratory Practices - Principles and Guidance to Regulations for Ensuring Data Integrity in Automated Laboratory Operations \|author=U.S. Environmental Protection Agency \|publisher=U.S. Environmental Protection Agency \|date=10 August 1995 \|archivedate=21 October 2013}}</ref>

	The GALP's creation was based on six principles<ref name=GALPBook2>{{cite book \|author=Weinberg, Spelton & Sax, Inc. \|title=GALP Regulatory Handbook \|chapter=Chapter 1: Why GALPs??? \|year=1994 \|pages=8–9 \|publisher=CRC Press \|url=http://books.google.com/books?id=RfzlSKm581EC \|isbn=1566700256}}</ref>:		The GALP's creation was based on six principles<ref name="GALPBook2">{{cite book \|author=Weinberg, Spelton & Sax, Inc. \|title=GALP Regulatory Handbook \|chapter=Chapter 1: Why GALPs??? \|year=1994 \|pages=8–9 \|publisher=CRC Press \|url=http://books.google.com/books?id=RfzlSKm581EC \|isbn=1566700256}}</ref>:

	1. The system must provide a method of assuring the integrity of all entered data.		1. The system must provide a method of assuring the integrity of all entered data.
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	==Impact==		==Impact==

	GALP had a variable regulatory impact on laboratories and organizations early on. Pharmaceutical and biologics laboratories could practically ignore the regulations while the U.S. [[Food and Drug Administration]] (FDA) and EPA used GALP as a key guiding factor in its standards and contract renewal considerations.<ref name=GALPBook1 /> The ~~[[United States~~ Department of Energy~~\|Department of Energy]]~~ and Superfund programs tightly followed GALP's standards while others viewed GALP as something to be loosely interpreted.<ref name=GALPBook1 />		GALP had a variable regulatory impact on laboratories and organizations early on. Pharmaceutical and biologics laboratories could practically ignore the regulations while the U.S. [[Food and Drug Administration]] (FDA) and EPA used GALP as a key guiding factor in its standards and contract renewal considerations.<ref name="GALPBook1" /> The Department of Energy and Superfund programs tightly followed GALP's standards while others viewed GALP as something to be loosely interpreted.<ref name="GALPBook1" />

			==Further reading==
			* {{cite web \|url=http://www.epa.gov/irmpoli8/expiredpolicies/2185.pdf \|archiveurl=https://web.archive.org/web/20131021091515/http://www.epa.gov/irmpoli8/expiredpolicies/2185.pdf \|format=PDF \|title=EPA 2185 - Good Automated Laboratory Practices - Principles and Guidance to Regulations for Ensuring Data Integrity in Automated Laboratory Operations \|author=U.S. Environmental Protection Agency \|publisher=U.S. Environmental Protection Agency \|date=10 August 1995 \|archivedate=21 October 2013}}

	==References==		==References==

Shawndouglas: Added cat.

2012-03-02T23:33:23Z

Added cat.

← Older revision		Revision as of 23:33, 2 March 2012
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	==References==		==References==
	<references />		<references />

			<!---Place all category tags here-->
			[[Category:Regulatory information]]

Shawndouglas: Grammar.

2012-02-28T21:31:55Z

Grammar.

← Older revision		Revision as of 21:31, 28 February 2012
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	The '''Good Automated Laboratory Practices''' ('''GALP''') ~~were~~ a [[United States Environmental Protection Agency\|U.S. EPA-based]] conglomeration of "regulations, policies, and guidance documents establishing a uniform set of procedures to ensure the reliability and credibility of [[laboratory]] data."<ref name=LIMSPaszko>{{cite book \|author=Paszko, Christine; Paszko Turner; Elizabeth Turner \|title=Laboratory Information Management Systems \|chapter=Chapter 6: Regulatory Requirements \|year=2001 \|pages=59 \|publisher=CRC Press \|url=http://books.google.com/books?id=ycEqnzPl2lYC \|isbn=0824741412}}</ref> GALP is considered an expired policy by the EPA, though the true expiration date is not know.<ref>{{cite web \|url=http://www.epa.gov/irmpoli8/expiredpolicies/index.html \|title=Expired Policies/Directives - Office of Environmental Information - US EPA \|publisher=U.S. EPA \|accessdate=28 February 2012}}</ref>		The '''Good Automated Laboratory Practices''' ('''GALP''') was a [[United States Environmental Protection Agency\|U.S. EPA-based]] conglomeration of "regulations, policies, and guidance documents establishing a uniform set of procedures to ensure the reliability and credibility of [[laboratory]] data."<ref name=LIMSPaszko>{{cite book \|author=Paszko, Christine; Paszko Turner; Elizabeth Turner \|title=Laboratory Information Management Systems \|chapter=Chapter 6: Regulatory Requirements \|year=2001 \|pages=59 \|publisher=CRC Press \|url=http://books.google.com/books?id=ycEqnzPl2lYC \|isbn=0824741412}}</ref> GALP is considered an expired policy by the EPA, though the true expiration date is not know.<ref>{{cite web \|url=http://www.epa.gov/irmpoli8/expiredpolicies/index.html \|title=Expired Policies/Directives - Office of Environmental Information - US EPA \|publisher=U.S. EPA \|accessdate=28 February 2012}}</ref>

	==History==		==History==

Shawndouglas: Added expiration citation.

2012-02-28T20:55:22Z

Added expiration citation.

← Older revision		Revision as of 20:55, 28 February 2012
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	The '''Good Automated Laboratory Practices''' ('''GALP''') ~~are~~ a [[United States Environmental Protection Agency\|U.S. EPA-based]] conglomeration of "regulations, policies, and guidance documents establishing a uniform set of procedures to ensure the reliability and credibility of [[laboratory]] data."<ref name=LIMSPaszko>{{cite book \|author=Paszko, Christine; Paszko Turner; Elizabeth Turner \|title=Laboratory Information Management Systems \|chapter=Chapter 6: Regulatory Requirements \|year=2001 \|pages=59 \|publisher=CRC Press \|url=http://books.google.com/books?id=ycEqnzPl2lYC \|isbn=0824741412}}</ref>		The '''Good Automated Laboratory Practices''' ('''GALP''') were a [[United States Environmental Protection Agency\|U.S. EPA-based]] conglomeration of "regulations, policies, and guidance documents establishing a uniform set of procedures to ensure the reliability and credibility of [[laboratory]] data."<ref name=LIMSPaszko>{{cite book \|author=Paszko, Christine; Paszko Turner; Elizabeth Turner \|title=Laboratory Information Management Systems \|chapter=Chapter 6: Regulatory Requirements \|year=2001 \|pages=59 \|publisher=CRC Press \|url=http://books.google.com/books?id=ycEqnzPl2lYC \|isbn=0824741412}}</ref> GALP is considered an expired policy by the EPA, though the true expiration date is not know.<ref>{{cite web \|url=http://www.epa.gov/irmpoli8/expiredpolicies/index.html \|title=Expired Policies/Directives - Office of Environmental Information - US EPA \|publisher=U.S. EPA \|accessdate=28 February 2012}}</ref>

	==History==		==History==

Shawndouglas: Added internal links.

2012-02-25T23:20:30Z

Added internal links.

← Older revision		Revision as of 23:20, 25 February 2012
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	The '''Good Automated Laboratory Practices''' ('''GALP''') are a [[United States Environmental Protection Agency\|U.S. EPA-based]] conglomeration of "regulations, policies, and guidance documents establishing a uniform set of procedures to ensure the reliability and credibility of laboratory data."<ref name=LIMSPaszko>{{cite book \|author=Paszko, Christine; Paszko Turner; Elizabeth Turner \|title=Laboratory Information Management Systems \|chapter=Chapter 6: Regulatory Requirements \|year=2001 \|pages=59 \|publisher=CRC Press \|url=http://books.google.com/books?id=ycEqnzPl2lYC \|isbn=0824741412}}</ref>		The '''Good Automated Laboratory Practices''' ('''GALP''') are a [[United States Environmental Protection Agency\|U.S. EPA-based]] conglomeration of "regulations, policies, and guidance documents establishing a uniform set of procedures to ensure the reliability and credibility of [[laboratory]] data."<ref name=LIMSPaszko>{{cite book \|author=Paszko, Christine; Paszko Turner; Elizabeth Turner \|title=Laboratory Information Management Systems \|chapter=Chapter 6: Regulatory Requirements \|year=2001 \|pages=59 \|publisher=CRC Press \|url=http://books.google.com/books?id=ycEqnzPl2lYC \|isbn=0824741412}}</ref>

	==History==		==History==
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	2. The formulas and decision algorithms employed by the system must be accurate and appropriate.		2. The formulas and decision algorithms employed by the system must be accurate and appropriate.

	3. An audit trail that tracks data entry and modifications to the responsible individual is a critical element in the control process.		3. An [[LIMS feature#Audit trail\|audit trail]] that tracks data entry and modifications to the responsible individual is a critical element in the control process.

	4. A consistent and appropriate change-control procedure capable of tracking the system operation and application software is a critical element in the control process.		4. A consistent and appropriate change-control procedure capable of tracking the system operation and application software is a critical element in the control process.

Shawndouglas: /* History */ Typo.

2012-02-25T23:17:56Z

History: Typo.

← Older revision		Revision as of 23:17, 25 February 2012
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	Work on GALP was first started by the EPA in 1989 as an extension of its pre-existing [[good laboratory practice]] (GLP) requirements to what they saw as a state of increasing automation in laboratories.<ref name=GALPBook1>{{cite book \|author=Weinberg, Spelton & Sax, Inc. \|title=GALP Regulatory Handbook \|chapter=Chapter 1: Why GALPs??? \|year=1994 \|pages=2–4 \|publisher=CRC Press \|url=http://books.google.com/books?id=RfzlSKm581EC \|isbn=1566700256}}</ref> An additional revision was released in 1995 by the EPA.<ref name=EPAGALP>{{cite web \|last=[[United States Environmental Protection Agency]] \|title=Good Automated Laboratory Practices - Principles and Guidance to Regulations for Ensuring Data Integrity in Automated Laboratory Operations \|url=http://cfpub.epa.gov/ols/catalog/catalog_display.cfm?&FIELD1=SUBJECT&INPUT1=Automation&TYPE1=EXACT&item_count=45 \|publisher=U.S. EPA, Office of Information Resources Management \|date=1995 \|accessdate=25 February 2012}}</ref>		Work on GALP was first started by the EPA in 1989 as an extension of its pre-existing [[good laboratory practice]] (GLP) requirements to what they saw as a state of increasing automation in laboratories.<ref name=GALPBook1>{{cite book \|author=Weinberg, Spelton & Sax, Inc. \|title=GALP Regulatory Handbook \|chapter=Chapter 1: Why GALPs??? \|year=1994 \|pages=2–4 \|publisher=CRC Press \|url=http://books.google.com/books?id=RfzlSKm581EC \|isbn=1566700256}}</ref> An additional revision was released in 1995 by the EPA.<ref name=EPAGALP>{{cite web \|last=[[United States Environmental Protection Agency]] \|title=Good Automated Laboratory Practices - Principles and Guidance to Regulations for Ensuring Data Integrity in Automated Laboratory Operations \|url=http://cfpub.epa.gov/ols/catalog/catalog_display.cfm?&FIELD1=SUBJECT&INPUT1=Automation&TYPE1=EXACT&item_count=45 \|publisher=U.S. EPA, Office of Information Resources Management \|date=1995 \|accessdate=25 February 2012}}</ref>

	The GALP's creation was based of six principles<ref name=GALPBook2>{{cite book \|author=Weinberg, Spelton & Sax, Inc. \|title=GALP Regulatory Handbook \|chapter=Chapter 1: Why GALPs??? \|year=1994 \|pages=8–9 \|publisher=CRC Press \|url=http://books.google.com/books?id=RfzlSKm581EC \|isbn=1566700256}}</ref>:		The GALP's creation was based on six principles<ref name=GALPBook2>{{cite book \|author=Weinberg, Spelton & Sax, Inc. \|title=GALP Regulatory Handbook \|chapter=Chapter 1: Why GALPs??? \|year=1994 \|pages=8–9 \|publisher=CRC Press \|url=http://books.google.com/books?id=RfzlSKm581EC \|isbn=1566700256}}</ref>:

	1. The system must provide a method of assuring the integrity of all entered data.		1. The system must provide a method of assuring the integrity of all entered data.

Shawndouglas: Grammar.

2012-02-25T23:17:02Z

Grammar.

← Older revision		Revision as of 23:17, 25 February 2012
Line 1:		Line 1:
	The '''Good Automated Laboratory Practices''' ('''GALP''') are an [[United States Environmental Protection Agency\|U.S. EPA-based]] conglomeration of "regulations, policies, and guidance documents establishing a uniform set of procedures to ensure the reliability and credibility of laboratory data."<ref name=LIMSPaszko>{{cite book \|author=Paszko, Christine; Paszko Turner; Elizabeth Turner \|title=Laboratory Information Management Systems \|chapter=Chapter 6: Regulatory Requirements \|year=2001 \|pages=59 \|publisher=CRC Press \|url=http://books.google.com/books?id=ycEqnzPl2lYC \|isbn=0824741412}}</ref>		The '''Good Automated Laboratory Practices''' ('''GALP''') are a [[United States Environmental Protection Agency\|U.S. EPA-based]] conglomeration of "regulations, policies, and guidance documents establishing a uniform set of procedures to ensure the reliability and credibility of laboratory data."<ref name=LIMSPaszko>{{cite book \|author=Paszko, Christine; Paszko Turner; Elizabeth Turner \|title=Laboratory Information Management Systems \|chapter=Chapter 6: Regulatory Requirements \|year=2001 \|pages=59 \|publisher=CRC Press \|url=http://books.google.com/books?id=ycEqnzPl2lYC \|isbn=0824741412}}</ref>

	==History==		==History==

Shawndouglas: Added more content.

2012-02-25T23:00:54Z

Added more content.

← Older revision		Revision as of 23:00, 25 February 2012
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	The '''Good Automated Laboratory Practices''' ('''GALP''') are an [[United States Environmental Protection Agency\|U.S. EPA-based]] conglomeration of "regulations, policies, and guidance documents establishing a uniform set of procedures to ensure the reliability and credibility of laboratory data."<ref name=LIMSPaszko>{{cite book \|author=Paszko, Christine; Paszko Turner; Elizabeth Turner \|title=Laboratory Information Management Systems \|chapter=Chapter 6: Regulatory Requirements \|year=2001 \|pages=59 \|publisher=CRC Press \|url=http://books.google.com/books?id=ycEqnzPl2lYC \|isbn=0824741412}}</ref> Work on GALP was first started by the EPA in 1989 as an extension of its pre-existing [[good laboratory practice]] (GLP) requirements to what they saw as a state of increasing automation in laboratories. The GALP was based of six principles<ref name=~~GALPBook~~>{{cite book \|author=Weinberg, Spelton & Sax, Inc. \|title=GALP Regulatory Handbook \|chapter=Chapter 1: Why GALPs??? \|year=1994 \|pages=~~2–9~~ \|publisher=CRC Press \|url=http://books.google.com/books?id=RfzlSKm581EC \|isbn=1566700256}}</ref>:		The '''Good Automated Laboratory Practices''' ('''GALP''') are an [[United States Environmental Protection Agency\|U.S. EPA-based]] conglomeration of "regulations, policies, and guidance documents establishing a uniform set of procedures to ensure the reliability and credibility of laboratory data."<ref name=LIMSPaszko>{{cite book \|author=Paszko, Christine; Paszko Turner; Elizabeth Turner \|title=Laboratory Information Management Systems \|chapter=Chapter 6: Regulatory Requirements \|year=2001 \|pages=59 \|publisher=CRC Press \|url=http://books.google.com/books?id=ycEqnzPl2lYC \|isbn=0824741412}}</ref>

			==History==

			Work on GALP was first started by the EPA in 1989 as an extension of its pre-existing [[good laboratory practice]] (GLP) requirements to what they saw as a state of increasing automation in laboratories.<ref name=GALPBook1>{{cite book \|author=Weinberg, Spelton & Sax, Inc. \|title=GALP Regulatory Handbook \|chapter=Chapter 1: Why GALPs??? \|year=1994 \|pages=2–4 \|publisher=CRC Press \|url=http://books.google.com/books?id=RfzlSKm581EC \|isbn=1566700256}}</ref> An additional revision was released in 1995 by the EPA.<ref name=EPAGALP>{{cite web \|last=[[United States Environmental Protection Agency]] \|title=Good Automated Laboratory Practices - Principles and Guidance to Regulations for Ensuring Data Integrity in Automated Laboratory Operations \|url=http://cfpub.epa.gov/ols/catalog/catalog_display.cfm?&FIELD1=SUBJECT&INPUT1=Automation&TYPE1=EXACT&item_count=45 \|publisher=U.S. EPA, Office of Information Resources Management \|date=1995 \|accessdate=25 February 2012}}</ref>

			The GALP's creation was based of six principles<ref name=GALPBook2>{{cite book \|author=Weinberg, Spelton & Sax, Inc. \|title=GALP Regulatory Handbook \|chapter=Chapter 1: Why GALPs??? \|year=1994 \|pages=8–9 \|publisher=CRC Press \|url=http://books.google.com/books?id=RfzlSKm581EC \|isbn=1566700256}}</ref>:

	1. The system must provide a method of assuring the integrity of all entered data.		1. The system must provide a method of assuring the integrity of all entered data.
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	6. Consistent control of a system requires the development of alternative plans for system failure, disaster recovery, and unauthorized access.		6. Consistent control of a system requires the development of alternative plans for system failure, disaster recovery, and unauthorized access.

			==Impact==

			GALP had a variable regulatory impact on laboratories and organizations early on. Pharmaceutical and biologics laboratories could practically ignore the regulations while the U.S. [[Food and Drug Administration]] (FDA) and EPA used GALP as a key guiding factor in its standards and contract renewal considerations.<ref name=GALPBook1 /> The [[United States Department of Energy\|Department of Energy]] and Superfund programs tightly followed GALP's standards while others viewed GALP as something to be loosely interpreted.<ref name=GALPBook1 />


	==References==		==References==
	<references />		<references />

Shawndouglas: Formatting.

2012-02-25T22:29:00Z

Formatting.

← Older revision		Revision as of 22:29, 25 February 2012
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	1. The system must provide a method of assuring the integrity of all entered data.		1. The system must provide a method of assuring the integrity of all entered data.

	2. The formulas and decision algorithms employed by the system must be accurate and appropriate.		2. The formulas and decision algorithms employed by the system must be accurate and appropriate.

	3. An audit trail that tracks data entry and modifications to the responsible individual is a critical element in the control process.		3. An audit trail that tracks data entry and modifications to the responsible individual is a critical element in the control process.

	4. A consistent and appropriate change-control procedure capable of tracking the system operation and application software is a critical element in the control process.		4. A consistent and appropriate change-control procedure capable of tracking the system operation and application software is a critical element in the control process.

	5. Control of even the most carefully designed and implemented system will be thwarted if appropriate user procedures are not followed.		5. Control of even the most carefully designed and implemented system will be thwarted if appropriate user procedures are not followed.

	6. Consistent control of a system requires the development of alternative plans for system failure, disaster recovery, and unauthorized access.		6. Consistent control of a system requires the development of alternative plans for system failure, disaster recovery, and unauthorized access.

	==References==		==References==
	<references />		<references />