GxP is the umbrella for the good-practice quality regimes governing regulated life-science work: GLP (21 CFR Part 58) for nonclinical safety studies, GCP (ICH E6) for clinical trials, GMP (21 CFR 210/211 and EU Annex 1) for manufacturing, and GVP for pharmacovigilance. Each requires documented, validated, inspectable process. Software used in a GxP process is subject to computerised system validation, which is why regulated life-science vendors describe themselves as GxP-ready before they describe themselves as API-first.
GxP
Statute International
Referenced in API Evangelist papers
This regulation shows up in my published research. These reports read the machine-readable evidence provider by provider — and put this regulation in the context of a real sector.
The State of Biotechnology APIs
GMP is named by 27 companies, GxP by 18, GLP by 16 — collectively the vocabulary this industry actually shares. 76 of 999 companies describe how they are audited; 14 describe how they interoperate.
Implemented by these standards
A regulation is the law; a standard is the machine-readable contract that makes it real. These are the technical standards that implement this regulation, catalogued at standards.apievangelist.com.
CDISC
GCP-governed trials produce the datasets CDISC standardizes.
