Difference between revisions of "Good Automated Laboratory Practices"

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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>:
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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>
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==History==
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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>
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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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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.
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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.
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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.
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==Impact==
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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 />
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==References==
 
==References==
 
<references />
 
<references />
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[[Category:Regulatory information]]

Latest revision as of 23:33, 2 March 2012

The Good Automated Laboratory Practices (GALP) was a 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."[1] GALP is considered an expired policy by the EPA, though the true expiration date is not know.[2]

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.[3] An additional revision was released in 1995 by the EPA.[4]

The GALP's creation was based on six principles[5]:

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.

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.

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.

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.[3] The Department of Energy and Superfund programs tightly followed GALP's standards while others viewed GALP as something to be loosely interpreted.[3]


References

  1. Paszko, Christine; Paszko Turner; Elizabeth Turner (2001). "Chapter 6: Regulatory Requirements". Laboratory Information Management Systems. CRC Press. pp. 59. ISBN 0824741412. http://books.google.com/books?id=ycEqnzPl2lYC. 
  2. "Expired Policies/Directives - Office of Environmental Information - US EPA". U.S. EPA. http://www.epa.gov/irmpoli8/expiredpolicies/index.html. Retrieved 28 February 2012. 
  3. 3.0 3.1 3.2 Weinberg, Spelton & Sax, Inc. (1994). "Chapter 1: Why GALPs???". GALP Regulatory Handbook. CRC Press. pp. 2–4. ISBN 1566700256. http://books.google.com/books?id=RfzlSKm581EC. 
  4. United States Environmental Protection Agency (1995). "Good Automated Laboratory Practices - Principles and Guidance to Regulations for Ensuring Data Integrity in Automated Laboratory Operations". U.S. EPA, Office of Information Resources Management. http://cfpub.epa.gov/ols/catalog/catalog_display.cfm?&FIELD1=SUBJECT&INPUT1=Automation&TYPE1=EXACT&item_count=45. Retrieved 25 February 2012. 
  5. Weinberg, Spelton & Sax, Inc. (1994). "Chapter 1: Why GALPs???". GALP Regulatory Handbook. CRC Press. pp. 8–9. ISBN 1566700256. http://books.google.com/books?id=RfzlSKm581EC.