GACP Guide 2025 for medical cannabis: implementing EMA Revision 1
- Riccardo Longato
- Jan 3
- 8 min read
Updated: 6 days ago
Introduction to GACP
If you produce medical cannabis, the 2025 GACP revision changes the game. In this clear guide you’ll discover what has changed, why it matters and how to adapt without risks.
Good Agricultural and Collection Practice (GACP) from the European Medicines Agency (EMA) is the foundation of quality control for plant substances intended for medicinal products. Revision 1, adopted in July 2025, updates GACP practices for the first time since 2006, adapting them to the technological progress of the last decade, particularly the spread of indoor cultivation. The document clarifies that cultivation, harvesting and primary processing directly influence the quality of herbal substances and require an adequate quality assurance system. For operators in the medical cannabis sector, implementing GACP is not optional: it represents the condition for accessing the pharmaceutical supply chain and ensuring patient safety.
GACP is a quality assurance system that controls the entire production cycle of medicinal plants: from seed identification and traceability, to cultivation, harvesting and primary processing. Revision 1 updates the document taking into account technological progress and legal practices published in recent years. It is reiterated that the choice of production method (wild collection, field cultivation, greenhouse or indoor) influences quality and must be carefully assessed.
The guideline establishes that contracts between producer and buyer must reference GACP and that compliance must be verified through regular audits. This confirms that GACP is the first step towards compliance with Good Manufacturing Practice (GMP). Without GACP-compliant starting material, it is not possible to obtain GMP certification required for market authorization.
Updates of Revision 1 (2025)
Revision 1 represents a full modernization of GACP. The update aims to align the guideline with current standards and includes additional provisions for indoor cultivation. Industry commentators highlight that the most relevant changes concern:
Recognition of indoor cultivation
Revision 1 introduces Annex 1, which defines specific requirements for indoor facilities, including systems controlling air, climate, humidity and light. Facilities must minimise contamination, facilitate cleaning and maintenance, and control staff access. Agronomic parameters and all materials used must be documented, with daily records for critical processes.
For indoor cultivation, critical quality attributes (CQA) and critical process parameters (CPP) must be identified, acceptance criteria defined for in-process controls, and cultivation processes standardized. Critical equipment must be qualified.
Traceability and documentation
The new GACP requires unequivocal lot traceability and the archiving of documentation at every stage, including audit reports.Daily digital records become the norm.Industry articles emphasize that paper-based systems will no longer be sufficient.
Contamination Control
Revision 1 introduces specific measures to prevent contamination from pyrrolizidine alkaloids (PAs), tropane alkaloids (TAs), and polycyclic aromatic hydrocarbons (PAH). Cultivation on land contaminated with sludge, heavy metals or pesticide residues is prohibited, and the minimal and justified use of fertilizers and plant protection products is recommended. Where irrigation is used, the water must comply with applicable national/international standards.
Producers must comply with international conventions such as CITES and the Nagoya Protocol, and must document the origin of seeds and propagation material.
GACP requirements from sowing to distribution
Seeds must come from plants accurately identified (genus, species, variety/cultivar/chemotype) and must be traceable; the same applies to vegetative propagation.
The starting material must be free from pests and diseases and, where possible, come from resistant varieties.
Seeds and cuttings must be free from seeds of other species, particularly those containing toxic components such as pyrrolizidine alkaloids.
How to integrate GACP into your QMS
Cultivation
Cultivation method
It must be described and documented, with attention to environmental impact and crop rotation.
Soil and fertilization
Cultivation on land contaminated with sludge, heavy metals or pesticides is prohibited.Manure must be composted or applied before the start of the cultivation cycle and must be free from microbial and human contamination. The use of fertilizers must avoid contamination from PCB and PAH.
Irrigation
Must be controlled according to the needs of the plant, and the water must comply with applicable quality standards.
Crop protection
Poisonous weeds must be removed and pesticides should be avoided wherever possible; if necessary, only approved products must be used, applied at the minimum effective level by qualified personnel, respecting pre-harvest intervals and residue limits. The risk of contamination from neighbouring crops must also be assessed.
Harvesting, Primary Processing and Packaging
Harvest and identification
Harvesting must be supervised, comply with species conservation laws and avoid damage to habitats. Endangered species must not be collected without authorization.
Personnel and training
Collectors must be able to identify the target species and distinguish it from similar plants to avoid health risks, as well as recognize diseased plants. They must also know the correct harvesting and post-harvesting techniques.
Primary processing
Includes washing, cutting, drying or other operations; it must comply with hygiene guidelines, with trained staff and documented procedures.
Packaging
The guideline recommends packing the herbal material early in clean and dry bags, sacks or boxes, preferably new ones. Labels must be permanent, clear and made from non-toxic materials. It is necessary to ensure that packaging materials do not contaminate the product; they must be suitable for food contact under applicable regulations.
Storage and distribution
Packaged products must be stored in dry and ventilated buildings, with controlled environmental conditions and protection from mold and exhaust gases. Before shipment, the hygiene conditions of the vehicle must be verified and documented.
GACP Standards for Indoor Cultivation: Requirements for Advanced Facilities
Annex 1 introduces, for the first time, provisions dedicated to indoor cultivation:
Facilities and systems
Indoor cultivation sites must be equipped with systems controlling air, climate and humidity, light, filtration and water treatment; they must be designed to limit contamination, facilitate cleaning and allow access control.
Documentation
All agronomic conditions and materials used must be documented. Critical parameters must be monitored daily and recorded digitally; cleaning activities must be recorded in the batch records.
Process validation
CQA and CPP must be identified, in-process acceptance criteria must be defined, and critical equipment must be qualified. Experts stress that indoor cultivation will require process standardization and regular equipment calibration.
GACP Compliance Checklist: Risk Management for Cannabis Leaders
GACP is a risk-management tool. Ignoring its principles results in significant business risk:
Risk Area | Brief Business Implications | |
Contamination | Risk of product rejection, patient harm and regulatory action due to contamination from heavy metals, pesticides or microbial agents. | |
Inconsistent Quality | Inability to produce standardized APIs, leading to batch failure and loss of buyer confidence. | |
Poor Documentation | Lack of traceability breaks supply chain integrity, making GMP compliance impossible. | |
Legal Non-Compliance | Violations of environmental regulations (CITES, Nagoya) may result in sanctions and reputational damage. | |
Inadequate Personnel | Untrained staff may cause misidentification, improper harvesting and poor hygiene, compromising final product quality. |
Implementing GACP: Practical Steps
Integrate GACP into your Quality Management System (QMS):
Treat it as the foundation of your QMS and ensure it flows naturally into the GMP framework.
Invest in personnel
Provide documented training on plant identification, hygiene and GACP procedures. The guideline requires qualified and adequately trained staff.
Prioritize traceability
Implement a robust documentation system tracking every input and process from seed to packaged batch. Without traceability you cannot prove compliance.
Schedule regular audits
Plan internal and external audits for all cultivation, collection and processing sites, including suppliers, as required by the guideline.
Control the environment
For indoor cultivators, use environmental control as a strategic advantage. Define and validate critical process parameters; document daily to ensure batch consistency.
And finally, the operational step is to work with a specialised consultant who can design and implement a Quality Management System for you, structure the documentation, and translate everything discussed in this article into a working compliance framework tailored to your organisation.
Knowing the requirements is only the first step, implementing them effectively inside a management system is what protects your business. This is why you should contact one of our experts today to book a free introductory consultation
FAQ - GACP & EMA Revision 1 (Medical Cannabis)
What is GACP in medical cannabis?
GACP (Good Agricultural and Collection Practice) is the EU regulatory framework that governs how medicinal plants, including medical cannabis, must be cultivated, harvested, handled, and documented to ensure pharmaceutical-grade raw material quality.
Who issues the GACP rules in Europe?
GACP rules are issued by the European Medicines Agency (EMA) through EudraLex Volume 4, Part II, and the HMPC Guideline on Good Agricultural and Collection Practice.
What is EMA GACP Revision 1 (2025)?
Revision 1 is the 2025 update of the EMA GACP guideline that introduces pharmaceutical-grade controls for indoor cultivation, traceability, contamination control, and data integrity, aligning cannabis cultivation with GMP principles.
Why was GACP updated in 2025?
Because modern cannabis production is no longer traditional agriculture. Indoor, climate-controlled cannabis cultivation behaves like pharmaceutical manufacturing, so EMA updated GACP to reflect this reality.
Does GACP apply to indoor cannabis cultivation?
Yes. Revision 1 explicitly recognizes indoor and controlled-environment cultivation as part of GACP, requiring defined environmental parameters, contamination controls, and validated cultivation processes.
Is GACP mandatory for medical cannabis in the EU?
Yes. Any cannabis used as an active pharmaceutical ingredient (API) or herbal drug substance must be produced under GACP before it can enter GMP manufacturing.
What happens if a grower is not GACP compliant?
Their cannabis cannot legally be used for pharmaceutical manufacturing in the EU, even if it passes lab testing. Non-GACP material is legally non-pharmaceutical.
How does GACP differ from GMP?
GACP governs cultivation and primary processing. GMP governs extraction, manufacturing, packaging, and batch release. GACP is the pharmaceutical starting point of the supply chain.
Can GACP cannabis be sold without GMP?
Yes, but only as raw pharmaceutical starting material. Any extraction, formulation, or packaging for patients requires GMP.
Does GACP include harvesting and drying?
Yes. Revision 1 explicitly includes harvesting, trimming, drying, curing, and primary packaging as part of controlled GACP operations.
Can a cultivator be both GACP and GMP?
Yes, but GACP always governs the cultivation part even inside GMP facilities.
Does Revision 1 apply retroactively?
Yes. Existing growers must upgrade their systems to comply.
About the Author
Riccardo Longato is an Italian entrepreneur, former ISO 9001 Auditor with a background in quality management systems implementation and quality assurance in the pharmaceutical industry. In 2023, together with his brother Fabrizio Longato, he co-founded Clear S.r.l. Benefit Corporation, a company that combines technical expertise and ethical vision to help businesses and institutions build solid, transparent compliance infrastructures in highly regulated sectors such as the medical cannabis industry, providing certification, quality assurance, and compliance support services.
Before founding Clear, Riccardo worked as an independent consultant, assisting companies of various sizes in developing management systems aligned with ISO standards. His approach is grounded in the belief that regulation should not be seen as bureaucracy, but as a tool to foster clarity, accountability, and lasting trust.
With Clear, Riccardo contributed to the creation of the Clear Certification Standard (CCS™), a globally recognized international certification model dedicated to ensuring the quality of pharmaceutical raw materials. Today, Clear works with producers, pharmaceutical companies, and regulatory authorities to ensure traceability, data integrity, and product quality, from cultivation to the patient.
In Italy, Riccardo also serves as Managing Partner of Clear Italia, supporting companies and organizations in developing management systems, structured financing initiatives, and modern governance models. His mission is to transform compliance obligations into strategic pathways for growth and transparency.
Active internationally, Riccardo also participates as a speaker and contributor in discussions on the future of medical cannabis, advocating for ethical, safe, and patient-centered supply chains that strengthen responsible enterprises.
Official References
EMA – Guideline on Good Agricultural and Collection Practice (GACP), Revision 1 (2025)https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-agricultural-collection-practice-gacp-starting-materials-herbal-origin-revision-1_en.pdfOfficial guideline issued by the European Medicines Agency defining Good Agricultural and Collection Practice for medicinal plants, including medical cannabis.
EMA – GACP Scientific Guideline (Official overview page)https://www.ema.europa.eu/en/good-agricultural-collection-practice-starting-materials-herbal-origin-scientific-guidelineEMA official landing page for GACP, providing access to the current Revision 1 and its regulatory framework.
European Commission – EudraLex Volume 4 (EU GMP Guidelines)https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_enThe official European Union collection of Good Manufacturing Practice guidelines governing pharmaceutical manufacturing and active substances.
EU GMP Annex 7 – Manufacture of Herbal Medicinal Productshttps://health.ec.europa.eu/system/files/2016-11/annex7_herbal_en_0.pdfEU GMP Annex regulating the manufacture and control of herbal medicinal products and botanical starting materials used in pharmaceuticals.
EMA – Good Manufacturing Practice (GMP) Regulatory Overviewhttps://www.ema.europa.eu/en/human-regulatory-overview/research-development/compliance-research-development/good-manufacturing-practiceEMA regulatory page explaining GMP principles, inspections, and compliance expectations across the EU pharmaceutical sector.
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