GACP software for medical cannabis cultivation
What GACP is and where it stops
The Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin, reference EMA/HMPC/246816/2005, is published by the European Medicines Agency and was written by its Committee on Herbal Medicinal Products (HMPC). The first version came into effect on 1 August 2006. Revision 1, adopted by the HMPC on 9 July 2025, updates it to current practice and adds an annex with provisions for indoor cultivation.
The guideline covers cultivation, collection, harvesting and primary processing of medicinal plants whose herbal substances are used to make herbal medicinal products, and is to be read with EU-GMP Part II and Annex 7. It also expects the producer and the buyer to put their agreement in writing with reference to GACP, and the buyer to verify compliance through regular audits of the cultivation sites and processing facilities.
Where GACP ends and GMP begins is set out in the table in EU-GMP Annex 7: cultivation, collection and harvesting fall under GACP, while further cutting and drying fall under GMP; only initial steps in the field that the marketing authorisation justifies stay under GACP. The manufacturer of the medicinal product is responsible for applying the right GMP classification, which depends on how the material is used.
What the guideline expects you to record
Section 7 of the guideline asks for a field record agreed between the grower and the buyer. It should document:
- the processes that may affect quality, such as training, personal hygiene, cleaning and maintenance, irrigation, fertilisation, applications of pesticides and herbicides, harvesting, processing and packaging;
- extraordinary circumstances during the growing period that may change the plant's chemical composition, such as extreme weather, pests or plant diseases;
- for cultivated plants, the location, the type, quantity and date of harvest, and the chemicals and other agricultural inputs used;
- any use of fumigants;
- batch assignment as early as possible, so that each batch of herbal substance is traceable to its source;
- the audit reports and written agreements between the producer and the buyer.
Section 8 adds that seeds and propagation material should be identified by genus, species, variety or chemotype and origin, and be traceable, with any change documented. Section 12 asks for drying conditions such as temperature, duration and method to be recorded in detail. For indoor cultivation, Annex 1 of the guideline asks for acceptance criteria for cultivation conditions to be documented for each batch, cleaning to be recorded in the batch records and logbooks, and daily (digital) records of critical process parameters to be kept and reviewed.
How Phyta Cultivate covers it
The table maps each expectation to what 365Phyta does and what remains your responsibility. Where the site does not describe a function, the table says so.
| GACP expectation | Where | What 365Phyta does | What stays with you |
|---|---|---|---|
| Batches traceable to their source, assigned as early as possible | GACP section 7 | Plant batches recorded from the mother plant and cutting onwards, so lot genealogy runs from cutting to lot. | Labelling practice in the grow rooms. |
| Identified, traceable propagation material | GACP section 8 | Mother plants and plant batches recorded, so each lot traces back to its mother plant. | Botanical identity and evaluation of seed and cutting suppliers. |
| Inputs used during production | GACP sections 7 and 9 | Inputs recorded against each plant batch. | Choosing and justifying inputs; plant protection rules. |
| Type, quantity and date of harvest | GACP sections 7 and 11 | Harvest recorded against the plant batch, with weigh-in on shared floor devices through Vanguard WMS Mobile. | Harvest procedures and hygiene. |
| Drying and other primary processing | GACP section 12; EU-GMP Annex 7 | Drying and trimming run as EU-GMP process orders with batch records in Phyta GMP (Processor and Integrated bundles). | The GMP classification of each step. |
| Waste plant material | GACP section 12 | Destruction register for waste and rejects in Phyta Narcotics. | Destruction method under national law. |
| Licensed plant numbers | National licence | Plant counts held against your licence in the licence register. | Keeping the licence itself current. |
| Training, hygiene, cleaning, irrigation and climate records | GACP sections 4 to 7; Annex 1 | Not described as a 365Phyta function on this site. | Your quality system and environmental monitoring; ask how they connect in a demo. |
Records are made at the step: growers and trimmers use shared handhelds or terminals with Vanguard WMS Mobile for plant moves, harvest weigh-in, sampling and destruction, and every entry is tied to a named user.
From cultivation record to EU-GMP batch
Your buyer's obligations explain what your records must contain. EU-GMP Annex 7 requires the manufacturer of a herbal medicinal product to use only herbal starting materials that meet GMP and the marketing authorisation, to hold documentation on audits of its suppliers, and to ensure that suppliers comply with GACP. The documentation for a herbal substance includes the scientific name of the plant with cultivar and chemotype where relevant, the source (country or region, cultivation, time of harvesting, possible pesticides used), the part of the plant used and, for a dried plant, the drying system.
In 365Phyta, starting-material documentation is carried from the cultivation record into the processing batch, so a processor on the same system does not re-key it. Per-shipment export permits are checked against the importer's permit before an order can be released. For groups that grow and process, GACP cultivation records flow into EU-GMP batch records without re-keying; see EU-GMP batch records.
Cultivation records in Germany under the MedCanG
Cultivating cannabis for medical purposes in Germany needs a permit from BfArM under section 4 of the Medical Cannabis Act (MedCanG). Section 16 then requires continuous records for each site and type of cannabis. For cultivation these include the location and size of the growing area and the sowing date, alongside the dates, quantities received and dispensed, and the resulting stock. The records are kept for three years, and the yield of the previous calendar year, with its growing area, is reported to BfArM by 31 January. The German country adapter produces the stock book and authority reports in the required format; see Germany: MedCanG and BfArM.
The grower's question: yield and cost per gram
The head of cultivation wants yield and cost per gram by strain, room and cycle. In 365Phyta, labour, inputs, energy and processing roll up into cost per gram for each lot, with yield by strain, room and cycle, on Business Central Essentials. Floor staff on shared devices need a floor device at €89 per device per month instead of a full user licence, with no 365Phyta user fee.
Where 365Phyta fits
Phyta Cultivate is part of the Grower bundle (Phyta Core, Cultivate and Narcotics, €249 per full user per month all-in) and the Integrated bundle. See 365Phyta for GACP cultivators, the compliance overview and the glossary.
FAQ
What is GACP?
Good Agricultural and Collection Practice: the guideline of the European Medicines Agency's Committee on Herbal Medicinal Products (EMA/HMPC/246816/2005) for cultivating, collecting, harvesting and primary processing of starting materials of herbal origin. Revision 1 was adopted on 9 July 2025.
Does GACP apply to indoor cultivation?
Yes. Revision 1 of the guideline adds an annex with provisions for indoor cultivation, including documented acceptance criteria for cultivation conditions for each batch and daily (digital) records of critical process parameters that are kept and reviewed.
Is drying and trimming covered by GACP or by GMP?
It depends on how the material is used. EU-GMP Annex 7 applies GACP to cultivation and harvesting, and GMP to further cutting and drying steps; the manufacturer of the medicinal product decides the GMP classification. In 365Phyta, drying and trimming run as EU-GMP process orders with batch records.
Does 365Phyta record grow-room climate data?
This site does not describe climate or environmental monitoring as a 365Phyta function. Phyta Cultivate records mother plants, plant batches, inputs, harvest and yield; ask in a demo how your climate records connect to them.
How is cost per gram calculated for a grower?
Labour, inputs, energy and processing roll up into cost per gram for each lot, with yield by strain, room and cycle, on Business Central Essentials.
Sources
- European Medicines Agency, Guideline on good agricultural and collection practice (GACP) for starting materials of herbal origin, EMA/HMPC/246816/2005 Rev. 1 (PDF).
- EudraLex Volume 4, Annex 7: Manufacture of Herbal Medicinal Products.
- European Commission, EudraLex Volume 4 (Part II).
- Medizinal-Cannabisgesetz (gesetze-im-internet.de): § 4 Erlaubnispflicht and § 16 Aufzeichnungen und Meldungen.
See a plant batch become a released lot
30 minutes with a Business Central consultant: mother plant, plant batch, harvest weigh-in and the lot your buyer receives.