Cannabis and Cannabis-Derived Products must be produced in compliance with Good Agricultural and Collection Practices (GACP), Good Production Practices (GPP), and Good Manufacturing Practices (GMP).
Using cannabis in medicine means its cultivation must abide by strict quality standards, such as the Good Production Practices (GPP), the Good Manufacturing Practices (GMP), and the GACP (Good Agricultural and Collection Practices).
Mivado GP consultants will help and support your facility’s compliance with GACP, GPP, and GMP by developing and Implementing a cost-effective Quality Assurance Program as per Health Canada, EU GMP, and US FDA regulations.
GACP
Implementation and deployment of GACP (Good Agricultural and Collection Practices) as a set of guidelines, SOPs, and policies covering areas of cultivation (from seeds and propagation material), collection, harvest, processing, packaging, personnel, equipment, documentation, and others for the sake of satisfying the minimum required quality assurance in plant cultivation.
GPP
Cannabis is considered a medicinal plant regardless of whether cultivated for recreational or pharmaceutical use. We support implementing a quality system because Cannabis facilities must be constructed and operated to meet GPP standards and to ensure cannabis is produced in a contamination-free environment so that will maintain its quality.
GMP
GACP and GPP Together with GMP, these guidelines completely define the entire process from seed to sale of all plants with Active Pharmaceutical Ingredients (APIs) to which cannabis belongs. GMP is to ensure that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production.
As a consultant specializing in Good Agricultural and Collection Practices (GACP), Good Production Practices (GPP), and Good Manufacturing Practices (GMP) for medical cannabis, Mivado GlobalPerformance offers a wide range of services to support companies in achieving compliance, optimizing operations, and ensuring product quality. Here’s a structured approach to our service offerings:
Regulatory Compliance & Certification Support
- Gap Analysis & Readiness Assessment: Evaluate current operations against GACP, GPP, and GMP requirements.
- Regulatory Pathway Guidance: Assist in understanding and complying with local and international regulations (e.g., EMA, WHO, EU-GMP, Canadian GPP, US FDA).
- Certification Preparation & Support: Guide businesses through certification processes, liaise with regulatory authorities, and support during inspections.
Facility Design & Qualification
- Facility Layout & Design Review: Ensure compliance with regulatory standards, focusing on controlled environments, workflow efficiency, and contamination prevention.
- Equipment Qualification (IQ, OQ, PQ): Support qualification of critical equipment for cultivation, processing, and manufacturing.
- HVAC & Environmental Control Strategies: Optimize climate control, air handling, and contamination prevention in cultivation and manufacturing areas.
Quality Management System (QMS) Implementation
- QMS Development & Documentation: Establish SOPs, batch records, deviation management, CAPA, and change control systems.
- Risk Assessment & Management: Implement HACCP, FMEA, and risk-based approaches to quality.
- Training Programs: Conduct employee training on GACP, GPP, GMP, and data integrity best practices.
Cultivation & Processing Optimization (GACP & GPP)
- Cultivation Best Practices: Implement standardized methods for strain selection, pest control, irrigation, and harvesting.
- Post-Harvest Processing Optimization: Ensure proper drying, curing, and storage to maintain cannabinoid and terpene profiles.
- Traceability & Batch Record Management: Implement electronic batch tracking systems to meet regulatory expectations.
GMP Manufacturing & Product Development
- Process Validation & Technology Transfer: Validate extraction, formulation, and packaging processes.
- Cleaning & Sanitization Programs: Develop robust protocols to prevent cross-contamination.
- Supplier & Raw Material Qualification: Ensure quality control of starting materials and supply chain integrity.
Auditing & Inspection Readiness
- Internal Audits & Mock Inspections: Conduct audits to identify gaps and corrective actions before regulatory inspections.
- Supplier & Third-Party Audits: Evaluate supply chain compliance with GACP, GPP, and GMP standards.
- Regulatory Inspection Support: Assist during inspections and with post-inspection CAPA implementation.
