On August 12th, 2025, EMA published the Revision 1 of the Good Agricultural and Collection Practice (GACP) guideline for starting materials of herbal origin. This update comes almost twenty years after the first version, and reflects technological developments, modern cultivation practices — including indoor and greenhouse systems — as well as the growing need for integration with Good Manufacturing Practice (GMP) requirements.  

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What are the main changes?

The revised GACP guideline introduces significant updates affecting nearly every stage of cultivation and primary processing. Key changes include, for example, stricter requirements for documentation, validation of critical processes, regular audits, and equipment qualification.

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What will be the new challenges for GACP Organizations?

As previously detailed, the revised GACP guideline establishes a clear requirement for compliance verification through regular audits, with organizations expected to provide documented evidence and ensure that all primary processes comply with competent authorities’ expectations.  

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To be effectively prepared to successfully receive audits and inspections, the companies should:

• Maintain real-time, complete documentation for every process step and changes.
• Update and standardize SOPs.
• Conduct regular, independent and complete self-inspections.
• Evaluate their suppliers of seeds and propagation materials.
• Validate sensitive operations, such as production processes and cleaning procedures.
• Implement strong risk management processes from cultivation to packaging of the final product.
• Ensure staff training and awareness, so teams can confidently perform their tasks and demonstrate compliance.

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The guideline’s revision emphasizes that compliance is no longer just about internal systems — companies must prove their controls are robust enough to withstand both internal and external scrutiny.

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The new GACP guideline is more than a regulatory update — it’s a push for higher quality, stronger risk management, and a challenge to integrate and align the operations with GMP requirements. This reflects in the following outcome:

• For auditors: sharper focus and higher expectations.
• For auditees: the need for robust systems and a proactive culture of quality.

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Compliance today is not just about passing audits — it’s about building trust in the supply chain and ensuring patient safety. Now more than ever, organizations should be able to ensure that every batch meets the highest criteria for safety and quality. In this context, understanding the changes to the GACP guideline is Key.

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