Bridging Cultivation and Compliance: Insights from the EU GACP 2025 Guideline Revision

The European medicinal cannabis industry continues to evolve rapidly, increasing the demand for harmonised quality systems and stronger regulatory oversight. The 2025 revision of the EU Good Agricultural and Collection Practice (GACP) Guideline marks a significant step forward, redefining how GACP and Good Manufacturing Practice (GMP) connect to ensure pharmaceutical-grade quality starts at cultivation.

Recently, I attended the EU GACP–GMP Interface Training led by Dr Markus Veit (Alphatopics). The session offered valuable insights into the revised guideline and highlighted how the update positions GACP as an integral part of the pharmaceutical quality framework. For professionals in Quality Assurance, Regulatory Affairs, or Medicinal Plant Operations, this marks a major shift toward tighter integration between cultivation and manufacturing.

Why the GACP–GMP Interface Matters

GACP governs every stage before manufacturing, from plant selection and cultivation to harvesting, processing, and storage. These steps determine the chemical composition, purity, and consistency of the final product.

Because medicinal cannabis is highly sensitive to environmental factors such as temperature, humidity, and light, even small deviations can alter its therapeutic profile. The 2025 revision addresses this by clarifying the interface between cultivation and GMP, ensuring that quality is built into each process rather than checked only at the end.

The updated framework now expects GACP systems to incorporate traceability, documentation, and risk management aligned with GMP-level standards, establishing unified quality expectations across the product lifecycle.

Key Updates in the 2025 GACP Revision

The new guideline introduces several essential requirements to ensure reproducible, traceable, and scientifically controlled cultivation:

• Validated environmental controls for drying and trimming, open-air or uncontrolled methods are no longer acceptable.

• Environmental monitoring for temperature, humidity, CO₂, and airflow to prevent contamination.

• Strain-specific process validation to maintain consistent cannabinoid and terpene profiles across harvests.

• Enhanced traceability from seed to shipment, with detailed documentation for cultivation, pest control, deviations, and harvests.

• Good Documentation Practice (GDocP) principles now embedded directly into GACP expectations.

• Mandatory record retention for supplier qualifications, audits, and batch documentation, aligning agricultural records with GMP archival standards.

Together, these changes elevate GACP from a procedural framework to a scientific, data-driven quality system built on continuous control.

Professional Reflections and Industry Impact

For QA and compliance professionals, the key message is clear: quality begins at cultivation. The 2025 revision closes the gap between growers and manufacturers by introducing pharmaceutical-grade expectations for documentation, validation, and oversight.

By fostering collaboration between cultivation, QA, QC, and regulatory teams, the new framework promotes consistent quality, stronger audit readiness, and greater product integrity.

The inclusion of GDocP principles at the cultivation level ensures that records generated in greenhouses or farms meet the same integrity standards as those in GMP environments, safeguarding authenticity and traceability.

Moreover, the focus on strain validation and environmental qualification reflects a move toward science-based risk management. This will not only reduce batch variability but also increase patient confidence in medicinal cannabis products.

A Culture of Compliance and Continuous Improvement

As Dr Markus Veit aptly stated, “GACP and GMP are now two sides of the same coin.” This embodies the spirit of the 2025 revision, quality and compliance are interconnected, not isolated.

For consultants, QA professionals, and producers, implementing these updates represents more than a regulatory obligation. It’s an opportunity to raise the standard for patient safety, transparency, and operational excellence. The transition may require planning, training, and system updates, but it ultimately strengthens the integrity of the entire supply chain.

In essence, the EU GACP 2025 revision reinforces that quality, safety, and traceability must begin at cultivation. By aligning agricultural practices with pharmaceutical expectations, the industry can ensure that medicinal cannabis products remain consistent, compliant, and scientifically validated from seed to final dose.

Authored by: Priyanka Kaushik, Quality Assurance Consultant – Fina Consultants