Good Agricultural and Collection Practices (GACP) and Good Manufacturing Practices (GMP) in the cannabis sector are essential regulatory standards ensuring the quality, safety, and consistency of medicinal cannabis. GACP focuses on cultivation, harvesting, and primary processing, ensuring optimal plant growth conditions. GMP, on the other hand, governs the manufacturing processes, including extraction, formulation, packaging, and quality control, to ensure pharmaceutical-grade products.
Compliance with GACP and GMP certification is crucial for the medical cannabis industry, as it guarantees patient safety, regulatory acceptance, and market credibility. Agropharm, leader in cannabis compliance solutions, helps businesses navigate these certifications, ensuring adherence to global pharmaceutical standards. This article aims to clarify the differences between GACP and GMP certification and highlight their roles in ensuring a high-quality medical cannabis supply chain. Understanding these certifications is vital for companies seeking to enter regulated markets and maintain consumer trust.
What is GACP?
Good Agricultural and Collection Practices (GACP) are a set of guidelines designed to ensure the safe, consistent, and high-quality cultivation and harvesting of crops, including medicinal cannabis. These practices regulate every step of the agricultural process to maintain product integrity and prevent contamination from environmental, chemical, or biological sources.
GACP aims to produce high-quality plant material by establishing strict controls over:
- Substrate Management: Ensuring nutrient-balanced, uncontaminated substrate for optimal plant growth.
- Irrigation: Regulating water quality and usage to optimize performance and prevent microbial contamination.
- Pest Control: Using safe, approved methods to prevent pests, diseases and pesticide residues in the final product.
- Harvesting & Handling: Implementing sanitary procedures in the standard operating procedures (SOPs) to avoid contamination and maintain cannabinoid consistency.
By enforcing these standards, GACP prevents impurities from entering the supply chain at the agricultural level, ensuring that only clean, potent plant material moves forward in the production process.
The World Health Organization (WHO) GACP guidelines serve as the primary global standard for medicinal plant cultivation. These guidelines outline best practices for sustainable and safe production, making GACP a foundation for GMP compliance in cannabis processing. Without proper GACP adherence, achieving GMP certification becomes challenging, even when there are different companies offering services dedicated to manage this transformation process from GACP to GMP, as the quality of raw material directly impacts pharmaceutical-grade cannabis production. This process is often called “GMP-Washing” when the operators that transform GACP raw materials into GMP raw materials misleadingly claims compliance with GMP standards without actually adhering to them.
Understanding the difference between GACP and GMP is essential for businesses aiming to meet regulatory requirements. While GACP governs cultivation, GMP oversees the manufacturing and final product formulation, creating a seamless quality control system from seed to sale.
What is GMP?
Good Manufacturing Practices (GMP) are a set of guidelines ensuring the safe, consistent, and high-quality processing of medicinal cannabis. While GACP focuses on cultivation, GMP regulates extraction, processing, packaging, and distribution, ensuring pharmaceutical-grade standards.
GMP enforces strict controls over:
- Hygiene & Sanitation: Preventing contamination during processing.
- Quality Control: Ensuring cannabis compounds content, purity, and stability.
- Process Validation: Standardizing production to reduce errors.
- Cross-Contamination Prevention: Avoiding unintended ingredient mixing.
GMP regulations vary by region:
- EU GMP: Essential for European pharmaceutical markets.
- US FDA GMP: Ensures drug safety and efficacy in US.
- Canada’s GMP: Overseen by Health Canada for medical cannabis approval.
Many countries outside of Europe voluntarily adopt EU-GMP standards for pharmaceutical and medicinal cannabis exports to the EU. Some countries even have formal Mutual recognition agreements (MRAs) with the EU, meaning their GMP inspections are considered equivalent.
While no country outside the US is “FDA-certified”, many have facilities inspected and approved by the FDA for compliance requirements, mainly for export purposes as well.
GACP and GMP certification are essential for companies entering the global cannabis market, ensuring compliance with pharmaceutical regulations and consumer safety.
Key differences between GACP and GMP
Understanding the difference between GACP and GMP is essential for ensuring compliance in the medical cannabis industry. While both certifications focus on quality and safety, they apply to different stages of production.
GACP (Good Agricultural and Collection Practices) regulates the cultivation and harvesting of medicinal cannabis. It ensures that plant materials are grown, collected, and handled under safe and standardized conditions. GACP covers soil or substrate management, water quality, pest and disease control, and harvesting techniques to maintain clean, high-quality raw materials for medicinal use. The WHO GACP guidelines serve as the primary global standard for these practices.
GMP (Good Manufacturing Practices) governs the processing and manufacturing of cannabis-derived products. It ensures that raw plant materials are transformed into pharmaceutical-grade medicines through strict controls over extraction, formulation, packaging, and quality assurance, between other variables. GMP compliance is regulated by authorities like the European Commission (EC), the European Medicines Agency (EMA), Food and Drugs Administration (FDA) or Health Canada, ensuring that cannabis products meet medical and pharmaceutical safety standards. According to EMA, GMP describes the minimum standard that a medicines manufacturer must meet in their production processes.
A verticaly integrated cannabis operation must first comply with GACP before achieving GMP certification, as GACP lays the foundation for quality raw materials. While both certifications share principles like contamination prevention and quality control, GMP enforces stricter pharmaceutical-level regulations on the final product.
Why both certifications are essential for medical cannabis production
GACP and GMP certification work together to create a fully compliant supply chain in medical cannabis production. GACP ensures that cannabis plants are cultivated, harvested, and handled under strict agricultural standards, minimizing contamination risks. This guarantees high-quality raw materials that can be used in pharmaceutical production.
However, GACP alone is not enough. Without it, raw materials may not meet the stringent purity and consistency standards required for GMP compliance. Conversely, without GMP, cannabis-derived products cannot achieve pharmaceutical-grade quality, making them unsuitable for medicinal use or regulatory approval.
GACP governs cultivation, while GMP ensures that post-processing meets medical and pharmaceutical standards, before transporting the goods through a GDP (Good Distribution Practices) company. Together, they provide a seamless quality assurance system, ensuring that medical cannabis products are safe, effective, and compliant with global regulations. For companies aiming to enter the regulated cannabis market, is essential to obtain either GACP, GMP, or both certifications.
How to achieve GACP and GMP certification in cannabis production
Achieving GACP and GMP certification requires strict adherence to regulatory guidelines. For GACP compliance, companies must implement proper documentation, appropiate facility building, optimized workflows, staff training, and environmental controls, between other variables, to ensure safe cultivation and harvesting. This includes monitoring substrate quality, irrigation, pests and diseases management, and sanitation practices.
For GMP compliance, companies must focus on pharmaceutical-grade facility design, quality assurance, and validation protocols. This involves strict hygiene controls, standardized manufacturing processes, and rigorous testing to ensure pharmaceutical-grade products.
Working with experienced consultants, like Agropharm and its partners, helps streamline certification, ensuring compliance with global cannabis regulations and facilitating market entry with high-quality, approved products and raw materials.
Ensure your cannabis production meets GACP and GMP certification standards with expert guidance. Contact Agropharm today for professional technical consulting and seamless compliance with global regulations.
