Good Manufacturing Practices (GMP) in the cannabis industry refers to a set of guidelines and practices that ensure the consistent production of safe and high-quality cannabis products. These practices cover everything from cultivation and harvesting to processing, packaging, and distribution.
GMP regulations require a systematic quality approach to manufacturing, including the development and implementation of procedures and documentation for the design, monitoring, and control of all manufacturing processes. This quality management system helps to ensure products are made consistently and reliably to product specifications for identity, strength, quality, and purity. Not only does GMP help businesses prevent hazards such as contamination or errors, it ensures that products are safe for consumers.
The Importance of GMP Certification
Cannabis GMP certification is crucial for various reasons, including:
- Ensuring consumer safety by preventing contamination and product adulteration.
- Maintaining product quality and consistency.
- Meeting regulatory requirements.
- Building consumer trust and brand reputation.
How can we help?
Cannaspire provides cannabis and psilocybin operators with the consulting and services to ensure success with becoming GMP certified. We are not the certifying body but assist and walk you through the GMP certification process.
What are the steps and process for achieving cannabis or psilocybin GMP certification?
- Facility Design and Layout:
Ensure that your facility is designed and laid out to meet GMP standards. This includes having a clean and organized facility with proper ventilation, sanitation, and security measures.
- Build a Baseline – GAP Analysis
The first step is to get a baseline of the facility. With the GMP certifying body checklist in hand, Cannaspire will conduct a GAP analysis of the facility to understand what the facility already has in place and what it still may need to complete the certification process. The GAP analysis consists of a facility evaluation to determine if all required fixtures are in place (hand sinks, for example), as well as an SOP/documentation evaluation to determine the scope of the existing quality management system.
- Choose a Certifying Body:
Next is to choose a GMP certifying body who will conduct the certification audit and issue the certification. Cannaspire will work with you to choose the certifying body that works best for your operation.
- Standard Operating Procedures (SOPs):
Cannaspire will develop, write and implement comprehensive SOPs and documentation for all aspects of your cannabis operation, including cultivation, processing, testing, packaging, and distribution. These SOPs will detail how each task is performed to meet GMP standards. Cannaspire will evaluate and update all existing SOPs documentation, and work with your team to create any additional SOPs and or documentation needed. Approximately 50 different SOPs and/or documents are required for cGMP certification.
- Personnel Training:
Cannaspire will train your staff in GMP principles, including hygiene, documentation, and product handling. This includes both initial training for new employees and ongoing training for existing staff. Cannaspire provides both onsite training and remote learning.
- Pre-Certification GAP Analysis:
Cannaspire will conduct a final GAP analysis to ensure the business is ready for the final certification audit and schedule the certification audit with the certifying body.
- Certifying Body Certification Audit:
This is when the certifying body auditor visits the facility to begin the audit process. Cannaspire will be onsite to answer questions, take notes and perform corrective actions.
- Corrective Action Plan:
If any deficiencies or non-compliance issues are identified during the certification process, Cannaspire will take immediate corrective actions to address them and provide them to the certifying body auditor.
- GMP Approval:
The corrective action plan has been accepted and all the time, hard work and money spent has now paid off. You are officially GMP certified!
- Ongoing Compliance:
Once certified the business needs to continue to follow GMP standards and regulations. Cannaspire will regularly review and update your procedures to stay in compliance with changing regulations and prepare for regular inspections and audits by regulatory agencies or third-party certifying bodies.
(ISO) International Standards Organization Certifications
ISO 17025: Testing Lab Competence
ISO 17025 is an internationally recognized standard for the competence of testing and calibration laboratories. It sets the criteria for laboratories to ensure that they can consistently produce accurate and reliable results, which is essential in the cannabis industry for quality control and compliance purposes.
- Demonstrates the technical competence of cannabis testing laboratories.
- Ensures the reliability of testing methods for potency, contaminants and quality control.
- Requires the use of validated methods and equipment.
- Establishes a quality management system to monitor and improve lab operations.
- Ensures accurate and reliable testing of cannabis products.
- Enhances consumer safety by reducing the risk of contaminated or mislabeled products.
- Facilitates compliance with regulatory requirements.
ISO 9001: Quality Management System
ISO 9001 is an internationally recognized standard that sets out the criteria for a Quality Management System (QMS). It helps organizations demonstrate their ability to consistently provide products and services that meet customer and regulatory requirements.
- Quality Control: Implementing ISO 9001 in the cannabis industry ensures rigorous quality control measures in cultivation, processing, and distribution.
- Compliance: Helps cannabis businesses comply with regulatory requirements, ensuring products meet safety and quality standards.
- Continuous Improvement: Encourages continuous improvement processes to optimize operations, enhance product quality, and increase customer satisfaction.
- Risk Management: Addresses risks associated with cannabis cultivation, production, and distribution, promoting effective risk management protocols.
- Enhanced Product Quality: Ensures high-quality cannabis products through standardized processes.
- Regulatory Compliance: Helps meet regulatory requirements and quality standards.
- Satisfaction: Focuses on meeting customer needs and improving satisfaction.
- Process Efficiency: Optimizes operations, reducing waste and enhancing productivity.
- Continuous Improvement: Encourages a culture of continuous enhancement in processes and products.
ISO 2200: Food Safety Management System
ISO 22000 is an international standard that specifies the requirements for a Food Safety Management system. It demonstrates a commitment to food safety, ensuring the safety of food products throughout the supply chain.
- Ensuring Safe Products: Addresses food safety hazards in the production and handling of cannabis-infused products.
- Supply Chain Management: Manages risks in the supply chain to prevent contamination or adulteration.
- Compliance: Helps comply with food safety regulations applicable to cannabis-infused consumables.
- Consumer Safety: Ensures safe consumption of cannabis-based edibles, oils, and other consumables.
- Hazard Control: Identifies and controls food safety hazards in cannabis products.
- Consumer Confidence: Builds consumer trust by ensuring the safety of cannabis-infused edibles and consumables.
- Compliance and Market Access: Facilitates compliance with food safety regulations, facilitating market access.
- Traceability: Establishes traceability measures for cannabis products through the supply chain.
- Risk Management: Addresses risks related to food safety, minimizing potential harm to consumers.
Organic Farm Certification
Hemp organic farming certification refers to a certification process that confirms hemp products have been cultivated and produced following strict organic farming practices. Organic certification ensures that the cultivation of hemp plants complies with specific standards set by the USDA.
The certification process typically involves detailed inspections of the hemp farms, verification of farming practices, and evaluation of the entire production process to ensure that it meets the defined organic standards. These standards often include guidelines regarding the use of synthetic pesticides, herbicides, fertilizers, genetically modified organisms (GMOs), and other prohibited substances. Organic certification also emphasizes sustainable farming methods, soil health, biodiversity, and environmental conservation.
Having a hemp organic farming certification indicates to consumers that the hemp product has been produced without the use of synthetic chemicals and adheres to environmentally friendly and sustainable agricultural practices. This certification can help consumers make informed choices about the products they purchase and supports farmers committed to ethical and eco-friendly farming methods.
Looking to achieve GMP, ISO or Organic Farming Certifications? Cannaspire can help.