Good Automated Laboratory Practices
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]
Further reading
- U.S. Environmental Protection Agency (10 August 1995). "EPA 2185 - Good Automated Laboratory Practices - Principles and Guidance to Regulations for Ensuring Data Integrity in Automated Laboratory Operations" (PDF). U.S. Environmental Protection Agency. Archived from the original on 21 October 2013. https://web.archive.org/web/20131021091515/http://www.epa.gov/irmpoli8/expiredpolicies/2185.pdf.
References
- ↑ Paszko, Christine; Paszko Turner; Elizabeth Turner (2001). "Chapter 6: Regulatory Requirements". Laboratory Information Management Systems. CRC Press. pp. 59. ISBN 0824741412. https://books.google.com/books?id=ycEqnzPl2lYC.
- ↑ "Expired Policies/Directives - Office of Environmental Information - US EPA". U.S. EPA. Archived from the original on 01 April 2015. https://web.archive.org/web/20150401070540/http://www.epa.gov/irmpoli8/expiredpolicies/index.html. Retrieved 15 April 2020.
- ↑ 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. https://books.google.com/books?id=RfzlSKm581EC.
- ↑ U.S. Environmental Protection Agency (10 August 1995). "EPA 2185 - Good Automated Laboratory Practices - Principles and Guidance to Regulations for Ensuring Data Integrity in Automated Laboratory Operations" (PDF). U.S. Environmental Protection Agency. Archived from the original on 21 October 2013. https://web.archive.org/web/20131021091515/http://www.epa.gov/irmpoli8/expiredpolicies/2185.pdf.
- ↑ Weinberg, Spelton & Sax, Inc. (1994). "Chapter 1: Why GALPs???". GALP Regulatory Handbook. CRC Press. pp. 8–9. ISBN 1566700256. https://books.google.com/books?id=RfzlSKm581EC.
