Two standards, one supply chain
GACP and EU GMP are both mandatory quality standards in the pharmaceutical cannabis supply chain, but they govern different stages of the process and have different scopes, different requirements and different oversight bodies. Understanding the distinction between them — and, critically, where one ends and the other begins — is one of the most practically important questions for any cannabis operator involved in supplying pharmaceutical markets.
The confusion between the two standards is understandable. Both use the word "good" in their names, both are required for pharmaceutical market access, and both are audited by inspectors and supply chain partners. But they were developed for different purposes, they are enforced by different regulatory frameworks, and the transition from GACP to GMP at the point where cultivation gives way to manufacturing is one of the most consequential and most frequently mismanaged interfaces in cannabis supply chains.
What GACP covers
Good Agricultural and Collection Practice (GACP) for herbal medicinal plant materials is defined in the EMA guideline EMEA/HMPC/246816/2005, which came into force in 2006. It was developed to address the specific quality challenges of herbal medicinal plant materials — materials derived from plants, where the quality of the starting material is determined primarily by agricultural and harvesting conditions rather than manufacturing operations.
GACP governs the cultivation, harvesting, drying, sorting and primary processing of medicinal plants intended for use as starting materials in pharmaceutical manufacturing. For cannabis specifically, GACP applies to the growing, harvesting, primary drying and initial size reduction of the cannabis plant.
The key GACP requirements for cannabis cultivation
- Site selection and environmental control — the cultivation site must be assessed for suitability, including proximity to pollution sources, soil quality, water quality and climate conditions. For indoor cannabis cultivation, the controlled environment reduces many of these risks, but they must still be formally assessed and documented.
- Seed and propagation material — the origin, identity and quality of planting material must be documented. For cannabis, this includes variety identification, genetic stability (particularly relevant for consistent cannabinoid profiles) and freedom from pests and disease at the point of propagation.
- Cultivation practices — the use of fertilisers, pesticides, growth regulators and water treatments must be controlled, documented and compliant with applicable regulations. Pesticide residues and heavy metal contamination are quality risks in cultivation that must be managed at the agricultural stage — they cannot be adequately controlled in manufacturing.
- Harvesting — harvesting methods, timing, handling and worker hygiene requirements must be defined and followed. The harvest window is critical for cannabinoid profile stability.
- Primary processing — drying, sorting and initial size reduction operations must be performed to prevent microbial contamination, degradation and adulteration. Temperature, humidity and airflow during drying are significant quality parameters for cannabis.
- Documentation — GACP requires records of cultivation operations, inputs, harvesting, primary processing, storage and transport. The documentation standard is less demanding than GMP but must be sufficient to support full traceability of each batch of plant material.
What GMP covers
EU GMP governs the manufacture of active pharmaceutical ingredients and medicinal products for human use. For cannabis, GMP applies from the point at which the cannabis plant material enters the manufacturing process as a starting material — typically when it is received by a licensed pharmaceutical manufacturer, weighed, sampled, and subjected to identity testing before being released for use in production.
EU GMP requires all the elements described in EudraLex Volume 4: pharmaceutical quality system, personnel training and competence, premises qualification, equipment qualification and validation, documentation and records, production process controls, quality control testing, quality assurance and the Qualified Person function. These requirements are substantially more demanding than GACP in their specificity, their documentation requirements and the depth of evidence required to demonstrate compliance.
The boundary between GACP and GMP
The precise boundary between GACP and GMP depends on the nature of the operations and the specific manufacturing process. EU GMP Annex 7 (Manufacture of Herbal Medicinal Products) provides guidance on where GMP requirements begin relative to herbal starting materials, with a table that maps different herbal material types to the applicable stages of GMP.
For cannabis, the practical demarcation is generally as follows:
- GACP: cultivation, harvesting, primary drying, sorting, initial milling or size reduction
- GMP starts at: receipt and testing of dried cannabis plant material as a pharmaceutical starting material, extraction, purification, formulation, packaging and all subsequent manufacturing steps
The EMA's current guidance and established industry practice in major markets — particularly Germany and the Netherlands — treat the dried, milled cannabis flower as a pharmaceutical starting material (or in some cases an active pharmaceutical ingredient), with GMP applying from the point of receipt. However, it is important to note that regulatory interpretation of the exact demarcation point varies between national competent authorities, and operators should seek specific guidance from their relevant national authority on where GMP begins in the context of their specific process.
Vertically integrated operations
Vertically integrated cannabis companies — those that both cultivate and manufacture — present a particular challenge because both standards apply within the same organisation, sometimes within the same building. These companies must clearly define and document the point at which their operations transition from GACP to GMP, and they must implement the appropriate quality systems, documentation and controls for each stage.
In practice, this means:
- Separate quality management procedures for GACP and GMP stages, with clearly defined responsibilities
- A formal material transfer process at the GACP-GMP boundary — including identity testing, weighing, labelling and QC release of the cannabis plant material as a starting material before it enters the GMP manufacturing process
- Separate batch documentation for GACP and GMP stages, or a single integrated batch record with a clearly defined transition point
- Personnel training covering both standards, with role-specific training appropriate to the stage of operations each person works in
- Physical or procedural separation between GACP and GMP areas to prevent contamination and ensure appropriate control at each stage
Reading Annex 7 correctly
Annex 7 of the EU GMP Guide is the key reference document for any cannabis operator trying to understand where GMP requirements begin in their specific supply chain. Table 1 in Annex 7 maps different types of herbal manufacturing starting points to the stages at which different parts of the GMP guide apply. For cannabis operations, the most relevant classification is typically "herbal drugs" or "herbal drug preparations" depending on the level of processing involved.
One important point that Annex 7 makes explicit: GMP requirements apply in increasing depth as the product progresses through the manufacturing process. Earlier stages — those closer to the cultivation end — have fewer GMP requirements applied to them than later stages. This staged application of GMP is intentional and reflects the different risk profiles of different manufacturing stages. It does not mean that early-stage manufacturing activities are uncontrolled — it means that the specific GMP controls applicable to those stages are more limited than those applied to later, higher-risk operations.
Common mistakes at the GACP-GMP interface
- No documented demarcation point — many operations have not formally defined and documented where GACP ends and GMP begins in their process. This means that inspectors and auditors cannot verify that appropriate controls are applied at each stage, even if the controls exist in practice.
- Insufficient starting material testing — cannabis plant material transferred from the GACP stage to the GMP stage is a pharmaceutical starting material and must meet defined specifications before use. These specifications must cover identity, purity, potency, microbial quality and, where applicable, pesticide residues and heavy metals. Some operations perform identity testing only, without the full specification testing required for a pharmaceutical starting material.
- Applying GMP documentation standards to GACP operations — attempting to apply full pharmaceutical GDP standards to cultivation records creates unnecessary administrative burden and is not required. GACP has its own documentation requirements, which are less demanding than GMP. The two standards should be applied appropriately to their respective stages.
- Applying GACP standards to manufacturing operations — the reverse error, where manufacturing operations are documented and controlled to agricultural quality standards rather than pharmaceutical GMP standards, is more serious and more common. This typically arises in operations that have grown from a GACP-focused background and have not yet made the cultural transition to pharmaceutical quality management.
Frequently asked questions
Can the same quality manager be responsible for both GACP and GMP?
Yes, in principle, though the person must be appropriately trained in both standards and the organisation must ensure that the quality system clearly documents the requirements of each. In larger operations with significant cultivation and manufacturing activities, it is common to have separate quality leads for each stage reporting into a common quality director. In smaller operations, a single qualified person may reasonably cover both standards provided the scope does not exceed their capacity.
Is GACP certification issued by a government body?
In the European Union, GACP is not typically certified by a national competent authority in the same way that EU GMP is. GACP compliance is usually assessed through customer audits, third-party audits and inspection by the relevant national competent authority as part of the supply chain audit process. Some national competent authorities — including the Portuguese INFARMED — include GACP compliance requirements in their licensing conditions for cannabis cultivators. In Germany, BfArM's oversight of domestic cannabis cultivation includes GACP compliance assessment.
Does GACP apply to indoor cannabis cultivation?
Yes. GACP applies to cannabis cultivation regardless of whether the growing environment is outdoor, greenhouse or controlled indoor environment. The specific requirements adapt to the growing environment — an indoor facility with full environmental control will have different GACP implementation details than an outdoor field crop — but the standard itself applies to all cultivation methods intended to produce cannabis as a pharmaceutical starting material.
Key takeaways
- GACP and EU GMP are separate standards governing different stages of the pharmaceutical cannabis supply chain.
- GACP applies to cultivation, harvesting, primary drying and sorting. EU GMP applies from the receipt of cannabis plant material as a pharmaceutical starting material through to finished product release.
- The boundary between GACP and GMP is defined in EU GMP Annex 7 and should be formally documented by every cannabis operator.
- Vertically integrated operators must implement both standards with a clearly documented and controlled transition point between them.
- Common mistakes include undocumented demarcation points, insufficient starting material testing at the GACP-GMP boundary, and applying one standard's documentation requirements to the other standard's activities.
References
- EMA/HMPC, Guideline on Good Agricultural and Collection Practice (GACP) for Starting Materials of Herbal Origin (EMEA/HMPC/246816/2005)
- EU GMP Annex 7 — Manufacture of Herbal Medicinal Products
- EudraLex Volume 4, Part I — Basic Requirements for Medicinal Products
- EudraLex Volume 4, Part II — Basic Requirements for Active Substances used as Starting Materials
Related content
What is EU GMP for Medical Cannabis? Pharmaceutical Quality Systems Explained GACP Implementation Checklist GACP-to-GMP Transition Guide