GALP
Good Automated Laboratory Practices
What a definition is not
A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
A discipline specifically addressing data integrity and quality controls for computerized systems used in regulated laboratories — instrument interfacing, raw data capture, audit trail, and archival of electronically generated laboratory data — originally issued by the US EPA and widely referenced as a model for laboratory computerized-system control.
GALP predates most modern computerized-system-validation frameworks and was developed specifically to address a gap that general GLP regulations did not fully anticipate: laboratory instruments and systems that generate, process, and store data electronically rather than on paper, and the data-integrity risks unique to that environment.
Its core expectations — that raw electronic data be captured directly and completely, that changes to data be attributable and traceable through an audit trail, and that electronic records be archived in a way that preserves their readability over the required retention period — anticipate many of the principles now expressed through ALCOA+ and modern computerized-system-lifecycle guidance.
Although GALP was originally issued for laboratories generating data under EPA-regulated testing programs, its principles are commonly cited by pharmaceutical and other GxP laboratories as an early, laboratory-specific articulation of data-integrity expectations for automated systems, predating comparable pharmaceutical-sector guidance by roughly a decade.
- —Originally an EPA framework for automated data systems in regulated laboratories
- —Addresses raw data capture, audit trail, and long-term archival readability
- —Anticipated many principles later formalized as ALCOA+
- —Widely cited outside EPA-regulated work as an early laboratory data-integrity model
US EPA, Good Automated Laboratory Practices (GALP), Office of Information Resources Management (1995)
Frequently asked questions
What does GALP stand for?
GALP stands for Good Automated Laboratory Practices.
What is GALP?
A discipline specifically addressing data integrity and quality controls for computerized systems used in regulated laboratories — instrument interfacing, raw data capture, audit trail, and archival of electronically generated laboratory data — originally issued by the US EPA and widely referenced as a model for laboratory computerized-system control.
Which regulations cover GALP?
US EPA, Good Automated Laboratory Practices (GALP), Office of Information Resources Management (1995)