**Posted on August 28, 2025**
Hello, GMP compliance enthusiasts! If you're involved in the world of herbal medicinal products, you've likely been keeping an eye on updates from the European Medicines Agency (EMA). The big news is that the Committee on Herbal Medicinal Products (HMPC) has finally adopted Revision 1 of the *Guideline on Good Agricultural and Collection Practice (GACP) for Starting Materials of Herbal Origin*. This update replaces the original guideline from 2006, bringing it in line with modern practices and technologies.
In this blog post, we'll break down the key changes in Revision 1 in simple terms. We'll focus on why this revision matters, what's new (especially for indoor cultivation), and how it impacts everyone from growers to manufacturers. Whether you're a cultivator, collector, or quality assurance professional, this guide will help you understand how to ensure the safety and quality of herbal starting materials. Let's dive in!
## Why Was the GACP Guideline Revised?
The original GACP guideline came into effect in August 2006 to ensure consistent quality for herbal substances used in medicines. Herbal medicines are complex—think plants like chamomile or ginseng—and their quality can be affected by everything from how they're grown to how they're harvested.
Over the past decade-plus, things have evolved:
- **Technological advances**: Indoor growing (like in controlled environments) has exploded in popularity. This allows better control over factors like light and humidity but brings new challenges.
- **Legal and practical updates**: Interpretations from documents like Annex 7 of the EU GMP Guidelines (from 2009) on manufacturing herbal products have been incorporated.
- **Patient safety focus**: With more awareness of contaminants (e.g., heavy metals, pesticides, or toxic weeds), the guideline now emphasizes reducing risks at every step.
Revision 1 keeps the core goal: establishing a quality assurance system for cultivation, collection, harvesting, and primary processing. It applies to all players in the supply chain—cultivators, harvesters, collectors, traders, processors, and manufacturers. For organic production, it overlaps with EU Regulation 2018/848, but GACP adds specific recommendations for medicinal plants.
The guideline stresses that wild collection vs. cultivation (outdoor, greenhouse, or indoor) each has pros and cons. For example, wild plants might vary more in composition, while cultivated ones offer better control but require careful management to avoid contamination.
## Key Sections of the Guideline: What's Stayed the Same and What's New?
The structure remains similar to the 2006 version, covering topics like quality management, personnel training, equipment, and more. But Revision 1 adds depth, especially on documentation, contamination prevention, and environmental considerations. Here's a breakdown, focusing on revisions:
### 1. **Executive Summary and Introduction**
- **What's new?** The summary highlights updates for indoor technologies and references recent legal insights. It notes that plant production directly affects herbal substance quality, and choices like wild vs. cultivated should consider risks (e.g., confusion with toxic plants in the wild).
- **Easy takeaway**: Think of this as the "why" section—ensuring herbs are safe and consistent for medicines.
### 2. **Scope**
- Covers cultivation (outdoor, greenhouse, indoor), collection from the wild, harvesting, and primary processing.
- **What's new?** Explicit links to GMP Part II (for APIs) and Annex 7. Stricter rules apply closer to the final product (e.g., higher standards for herbal teas than for extracts). It emphasizes patient safety by minimizing microbiological load and contaminants like pyrrolizidine alkaloids (PAs) or heavy metals.
- **Easy takeaway**: Everyone in the chain must document activities and comply with regulations like CITES (for endangered species) and the Nagoya Protocol (for genetic resources).
### 3. **Quality Management**
- Agreements between producers and buyers must reference GACP, with regular audits.
- **What's new?** More emphasis on verifying compliance through site audits by experts.
- **Easy takeaway**: It's like a contract ensuring quality—written down and checked regularly.
### 4. **Personnel and Training**
- Staff need hygiene training, protection from toxic plants, and knowledge of identification, pests, and best practices.
- **What's new?** Detailed training for collectors (e.g., spotting contaminated areas) and harvesters (e.g., IPM—Integrated Pest Management). For indoor setups, training on controlled climates is key. No smoking or eating near plants to avoid contamination.
- **Easy takeaway**: People are the first line of defense—train them well to spot issues like diseased plants or environmental risks.
### 5. **Building and Facilities**
- Buildings must be clean, pest-free, and protect against animals or fire.
- **What's new?** Recommendations for storage (e.g., on pallets, away from walls) and hygiene facilities. For indoor (see Annex 1), facilities need systems for air, light, and humidity control to minimize contamination.
- **Easy takeaway**: Keep things spotless—like storing food, but for medicinal plants.
### 6. **Equipment**
- Equipment must be clean, calibrated, and non-contaminating.
- **What's new?** Calibration for fertilizer/pesticide tools and post-use cleaning to prevent cross-contamination.
- **Easy takeaway**: Tools are extensions of your hands—keep them in top shape.
### 7. **Documentation**
- Field records must cover everything from location to pesticides used.
- **What's new?** Traceability for batches from different areas; mix only if homogeneous. For indoor (Annex 1), daily records of critical parameters (e.g., temperature) and validation procedures.
- **Easy takeaway**: Document like your quality depends on it—because it does!
### 8. **Seeds and Propagation Material**
- Seeds must be traceable, pest-free, and from identified plants.
- **What's new?** Emphasis on avoiding toxic seeds (e.g., those with PAs) and evaluating suppliers for changes.
- **Easy takeaway**: Start with good "ingredients" to grow quality plants.
### 9. **Cultivation**
- Covers soil, fertilization, irrigation, and plant protection.
- **What's new?** Avoid contaminated soils; justify fertilizer use; implement IPM to minimize pesticides. For indoor (Annex 1), identify critical attributes, standardize processes, and qualify equipment.
- **Easy takeaway**: Grow smart—rotate crops, use clean water, and monitor for pests.
### 10. **Collection**
- Supervise collectors; comply with conservation laws.
- **What's new?** Stronger focus on endangered species (CITES, Nagoya) and avoiding over-exploitation.
- **Easy takeaway**: Collect responsibly to protect nature.
### 11. **Harvesting**
- Harvest at optimal quality; avoid damage or wet conditions.
- **What's new?** Use food-compliant tools; protect from soil contact; document pest control.
- **Easy takeaway**: Time it right and handle gently to keep quality high.
### 12. **Primary Processing**
- Includes washing, drying, cutting; conform to GMP where needed.
- **What's new?** Avoid sun drying unless necessary; minimize fumigants (e.g., ban ethylene oxide); inspect and sieve materials.
- **Easy takeaway**: Process quickly and cleanly to prevent spoilage.
### 13. **Packaging**
- Use clean, labeled materials suitable for food contact.
- **What's new?** Reference to EU regulations for plastics.
- **Easy takeaway**: Package to protect and trace.
### 14. **Storage and Distribution**
- Store in dry, aerated conditions; check trucks for hygiene.
- **What's new?** Keep samples for 3 years; avoid moisture in humid areas.
- **Easy takeaway**: Store like valuables—safe and controlled.
### 15-16. **Definitions and References**
- New terms like "indoor cultivation" and contaminants (PAs, PAHs).
- Updated references to current regs and papers.
## Spotlight on Annex 1: Indoor Cultivation Provisions
This is the star of Revision 1! Indoor growing (e.g., in closed environments with artificial light) gets its own annex because it's booming. Key additions:
- **Facilities**: Control access, air filtration, and cleaning to prevent contamination.
- **Documentation**: Daily logs of parameters like temperature; validate processes.
- **Cultivation**: Written procedures for materials; calibrate equipment; standardize for reproducibility.
**Why focus here?** Indoor setups offer precision but risk inconsistencies if not managed well. This ensures reproducible quality.
## What Does This Mean for You?
If you're in the herbal supply chain, update your procedures now. Conduct audits, train staff, and document everything. Manufacturers: Ensure suppliers comply—it's your patient's safety on the line.
For the full guideline, check the EMA site: [Guideline on GACP](https://www.ema.europa.eu/en/good-agricultural-collection-practice-starting-materials-herbal-origin-scientific-guideline). See comments on the draft: [Overview of Comments](https://www.ema.europa.eu/en/documents/comments/overview-comments-received-draft-guideline-good-agricultural-collection-practice-gacp-starting-materials-herbal-origin-revision-1_en.pdf).
Questions? Drop a comment below. Stay compliant!
*Disclaimer: This post is for informational purposes. Always consult official sources for compliance.*
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