The global medicinal cannabis industry is undergoing a profound transformation, shaped by expanding regulatory frameworks, evolving patient needs, and increasing scientific validation.
From the mature markets of Canada and Australia to the rapidly developing regulatory landscapes of Argentina, Thailand, and beyond, countries are redefining how medical cannabis is cultivated, processed, and integrated into healthcare systems.
Producers are competing to deliver high-quality dried cannabis flowers that comply with complex regulatory frameworks tailored to each target market.
This raises a central question for the sector: Who verifies that producers truly comply with Good Agricultural and Collection Practices (GACP) and Good Manufacturing Practices (GMP)?
Like all quality assurance systems, compliance in medicinal cannabis cultivation is assessed through three distinct levels of inspection, each offering varying degrees of independence, credibility, and assurance.
Understanding these levels is crucial — and highlights why third-party audits have become an essential component of global medicinal cannabis quality assurance.
First Level: Self-Inspection (Internal Audit)
While the term self-inspection isn’t explicitly mentioned in EMA/HMPC/246816/2005 Rev. 1 GACP Guideline, the need for a documented quality assurance system is clear.
Organizations must maintain records, data, and traceable procedures demonstrating adherence to good cultivation practices. Conversely, GMP explicitly mandates internal audits (EU GMP Part I Chapter 9; Part II Chapter 2.5).
In this layer, organizations assess themselves, ensuring procedures are properly implemented and deviations are detected early. However, from the perspective of customers, regulators, or international buyers, this level carries the highest uncertainty, as the auditor and auditee are the same entity.
Second Level: Second-Party Audits
These business-to-business audits typically take place between customers and suppliers and are well established in medicinal cannabis guidelines. As stated in the revised EU GACP, Chapter 3:
“GACP compliance should be verified through regular audits of cultivation and/or processing sites by expert representatives of the buyer or manufacturer.”
Manufacturer Authorization Holders (MAHs) are also required under EU GMP Part II (7.11) and Part I (5.27) to maintain supplier evaluation and approval procedures, often including on-site audits.
Second-party inspections offer greater objectivity and accountability, bridging the gap between internal controls and full regulatory oversight.
Third-Party Audits: The Highest Level of Independence — and Why They Matter
Third-party audits are independent assessments performed by external organizations to evaluate compliance with defined standards, regulations, or internal controls. In the pharmaceutical sector, regulatory authorities typically conduct these audits for MAHs as required by law.
Another growing category involves certification bodies, which audit against international standards (e.g., ISO 13485, ISO 14644-5) or proprietary standards for medicinal cannabis such as private GACP schemes.
The essential distinction lies in what motivates them:
Why Third-Party Audits Matter for Medicinal Cannabis: Key Advantages
Though still limited, third-party certification presents a significant opportunity for the medicinal cannabis sector, especially at the GACP level. By introducing independent, transparent, and standardized verification, third-party audits can:
In a rapidly expanding and globally interconnected market, independent certification is becoming a strategic tool for producers seeking differentiation and long-term credibility.
Lessons Learned from the Field: Ensuring the Credibility of Third-Party Audits
While third-party audits are widely recognized as a cornerstone of quality assurance, the pharmaceutical industry often raises concerns regarding the independence of these assessments. Because the audited organization commissions and funds the audit, some stakeholders perceive a potential limitation in impartiality.
Two mechanisms can help reinforce confidence:
- Collaborative Development of Standards
When pharmaceutical companies participate in shaping the requirements of a certification scheme, the resulting standard gains credibility, practicality, and market relevance. Shared governance strengthens trust in the process.
- Accreditation by National Authorities
Accreditation provides an additional layer of assurance. It ensures certification bodies operate under recognized frameworks, meet strict competence and governance criteria, and undergo regular oversight. This reinforces confidence among producers, regulators, and healthcare stakeholders.
Together, these mechanisms enhance the integrity, transparency, and acceptance of third-party audits, balancing market needs with reliable and technically sound quality assurance.
Q-CERT’s Role in Advancing Independent Cannabis Quality Assurance
Recognizing the importance of credible third-party audits in medicinal cannabis, Q-CERT has obtained accreditation for its GACP standard for medical cannabis (Q-GACP). Developed on the basis of the EMEA Guideline, it currently stands as the only ISO 17065-accredited certification scheme worldwide in this field.
This accreditation strengthens global confidence in GACP compliance assessments and supports producers seeking reliable, independent verification to access regulated medicinal cannabis markets.