The GxPs - Good Laboratory Practice (GLP), Good Clinical Practice (GCP) or current Good Manufacturing Practice (cGMP) - are a set of federal regulations or internationally accepted quality guidance documents that govern how certain research projects are to be conducted. These projects are typically included in the application to the governing agency to obtain approval of the product, or approval to conduct clinical trials, and include those that procure or utilize human samples.
They do not typically include projects of a discovery, or exploratory nature (e.g., target identification, high throughput screening, early efficacy models, early safety studies).
Some of the project types that would require GxP services include:
- Agricultural or environmental toxicology studies or study phases under EPA GLP regulations, or equivalent (for non-U.S.)
- Pivotal Nonclinical Drug Safety Studies or study phases under FDA GLP regulations, or equivalent (for non-U.S.)
- Manufacturing, characterization or packaging of therapeutics (active pharmaceutical ingredients) for humans or companion animals under GMP guidance (ICH Q7) and/or FDA regulations (or equivalent for non-U.S.).
- Procurement or distribution of human-derived specimens or analysis of such specimens for exploratory purposes, e.g., biomarker identification, under certain requirements of GCP and patient/subject privacy laws (e.g., HIPAA), or for diagnostic purposes under federal certification (e.g., CLIA) or international accrediting programs (e.g., CAP).
- Human clinical trials and sample analyses required to be conducted under federal GCP and patient/subject privacy regulations.
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