Cannabis Quality & Regulatory Support & Services
We assist in ensuring full compliance for cannabis farmers under the South African Health Products Regulatory Authority (SAHPRA) regulations, including the Guideline for Cultivation of Cannabis and Manufacture of Cannabis-Related Pharmaceutical Products for Medicinal and Research Purposes (July 2024) and Good Agricultural Practices (GAP).
Our expert team, with over a decade of experience in pharmaceutical and agricultural regulatory compliance, offers end-to-end services to guarantee your Cannabis operation meets SAHPRA’s stringent quality, regulatory, and operational requirements. From licensing to daily operations, we are your trusted partner in navigating the complex landscape of medicinal cannabis cultivation.
Our Cannabis Solutions:
1. SAHPRA Licensing Support
What We Do: Guide farmers through the entire licensing process, from application preparation to site inspections.
How We Excel: We draft compliant applications, develop site plans, and ensure security and quality measures meet SAHPRA’s standards, maximising approval success.
Outcome: Secure your cultivation licence swiftly, with zero compliance gaps.
2. Tailored Quality Management System (QMS) Development
What We Do: Design and implement a robust QMS aligned with SAHPRA’s GAP, GMP (if applicable), and ISO 9001:2015 principles.
How We Excel: Our team crafts non-negotiable SOPs (e.g., Cultivation, Quality Control), Work Instructions, and Forms (e.g., CoA, Inventory Log), ensuring traceability, quality assurance, and audit readiness.
Outcome: A fully compliant QMS that streamlines operations and passes SAHPRA audits with ease.
3. Regulatory Compliance Assurance
What We Do: Ensure adherence to the Medicines and Related Substances Act, 1965, for Schedule 7 substances, including security, testing, and documentation.
How We Excel: We conduct gap analyses, implement corrective actions, and liaise with SAHPRA-accredited labs for potency and contaminant testing.
Outcome: 100% compliance with SAHPRA’s regulatory framework, minimising risks of penalties or licence revocation.
4. Security and Traceability Solutions
What We Do: Develop and install security plans and traceability systems to prevent diversion and ensure full seed-to-harvest tracking.
How We Excel: Our expertise in Schedule 7 compliance includes CCTV integration, access controls, and inventory software tailored to SAHPRA’s requirements.
Outcome: Ironclad security and traceability that safeguards your operation and satisfies regulators.
5. Staff Training and Competence Building
What We Do: Deliver customised training programs on GAP, QMS, security, and safety protocols.
How We Excel: Our trainers, with backgrounds in pharmaceutical compliance, provide hands-on sessions and competence assessments, ensuring staff readiness.
Outcome: A skilled workforce that upholds SAHPRA standards in daily operations.
6. Audit Preparation and Support
What We Do: Conduct internal audits and prepare farms for SAHPRA inspections.
How We Excel: We simulate SAHPRA audits, address non-conformities, and provide real-time support during inspections, leveraging our deep knowledge of PIC/S and GAP standards.
Outcome: Seamless audit success, reinforcing your farm’s compliance credibility.
7. Day-to-Day Operational Support
What We Do: Offer ongoing guidance on cultivation, quality control, and record-keeping to optimise operations.
How We Excel: Our cloud-based tools and dedicated consultants ensure real-time compliance monitoring, from batch tracking to environmental controls.
Outcome: Efficient, compliant daily operations that enhance productivity and quality.
8. Continuous Improvement and Market Access
What We Do: Drive QMS enhancements and align farms with international standards (e.g., ISO 9001) for export opportunities.
How We Excel: We analyze performance data, implement CAPA systems, and connect farmers with global pharmaceutical buyers.
Outcome: A future-proof operation ready for local and international markets.