GxP Disciplines

GACP

Good Agricultural and Collection 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.

The discipline governing the cultivation, wild collection, and primary processing of medicinal plants and other botanical starting materials, addressing seed/propagation material identity, growing conditions, harvest timing, drying, and initial processing to ensure consistent quality and minimize contamination before the material enters GMP-regulated manufacturing.

GACP sits upstream of GMP in the herbal and botanical supply chain: it governs everything from correct botanical identification and sustainable wild-collection practice through to post-harvest handling — drying, cutting, and initial packaging — that happens before the plant material is delivered to a GMP-licensed manufacturing site.

Because botanical starting materials are biological and subject to natural variability, agricultural inputs (fertilizers, pesticides), and environmental contamination (heavy metals, mycotoxins), GACP controls at the source are treated as a critical quality input rather than something that can be fully corrected by downstream testing alone.

Regulators expect traceability from the final herbal medicinal product back to the specific growing region, harvest, and collector, which is why GACP compliance is typically documented and, for some markets, independently audited as part of the supplier qualification of a botanical raw-material source.

KEY POINTS
  • Governs cultivation and wild collection of medicinal plants, upstream of GMP
  • Covers species identification, growing conditions, harvest timing, and post-harvest handling
  • Addresses agricultural and environmental contamination risks specific to botanicals
  • Supports traceability from finished herbal product back to growing region and harvest
REGULATORY BASIS

WHO Guidelines on Good Agricultural and Collection Practices (GACP) for Medicinal Plants (2003); EMA/HMPC Guideline on Good Agricultural and Collection Practice for Starting Materials of Herbal Origin

Frequently asked questions

What does GACP stand for?

GACP stands for Good Agricultural and Collection Practice.

What is GACP?

The discipline governing the cultivation, wild collection, and primary processing of medicinal plants and other botanical starting materials, addressing seed/propagation material identity, growing conditions, harvest timing, drying, and initial processing to ensure consistent quality and minimize contamination before the material enters GMP-regulated manufacturing.

Which regulations cover GACP?

WHO Guidelines on Good Agricultural and Collection Practices (GACP) for Medicinal Plants (2003); EMA/HMPC Guideline on Good Agricultural and Collection Practice for Starting Materials of Herbal Origin