GRP
Good Review Practice
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.
Good Review Practice refers to the documented policies, procedures, and standards a regulatory authority uses to conduct consistent, high-quality, and timely reviews of marketing applications and submissions. GRP documents describe how reviewers should evaluate evidence, structure their assessments, and apply standards uniformly so that decisions are predictable and defensible across reviewers and over time. It is the regulator-facing counterpart to industry's good practices: quality assurance applied to the review function itself.
GRP matters to industry even though it governs the authority, because it shapes what a well-constructed submission should anticipate: consistent review criteria mean a sponsor can prepare to the standard the reviewer will apply. FDA maintains a body of GRP documents (guidances, MAPPs, and SOPs) that codify review expectations.
The concept mirrors the broader GxP philosophy — documented procedures, consistency, and traceable decision-making — applied to the governmental assessment process rather than to manufacturing or clinical conduct.
- —Documented policies for consistent, timely regulatory review of submissions
- —Ensures uniform, predictable, defensible assessment decisions
- —The regulator-side analogue of industry good practices
- —Signals to sponsors the standard their submission will be judged against
FDA Good Review Practice documents (guidances, MAPPs, and SOPs).
Frequently asked questions
What does GRP stand for?
GRP stands for Good Review Practice.
What is GRP?
Good Review Practice refers to the documented policies, procedures, and standards a regulatory authority uses to conduct consistent, high-quality, and timely reviews of marketing applications and submissions. GRP documents describe how reviewers should evaluate evidence, structure their assessments, and apply standards uniformly so that decisions are predictable and defensible across reviewers and over time. It is the regulator-facing counterpart to industry's good practices: quality assurance applied to the review function itself.
Which regulations cover GRP?
FDA Good Review Practice documents (guidances, MAPPs, and SOPs).