The Certification Body Q-CERT, aiming to meet the market’s demand for certified services that ensure product quality, has developed the Q GACP private certification scheme for medical cannabis. This system offers an important quality assurance tool for producers and businesses involved in medicinal cannabis production.

The standard is based on the EU GACP guideline (EMEA/HMPC/246816/2005: GUIDELINE ON GOOD AGRICULTURAL AND COLLECTION PRACTICE (GACP) FOR STARTING MATERIALS OF HERBAL ORIGIN) and the guideline by the World Health Organization (WHO guidelines on good agricultural and collection practices (GACP) for medicinal plants: 2003). The certification process applied follows the international ISO 17065 standard, ensuring standardized processes that are globally recognized, with audits conducted by experienced and technically trained personnel familiar with both audit techniques and cannabis cultivation.

As the demand for medicinal cannabis expanding worldwide, the need for certified products that meet the stringent requirements of the pharmaceutical industry becomes increasingly critical.

What is the GACP Certification Scheme for medical cannabis?

The GACP is a specialized quality assurance certification scheme applied to the cultivation of medicinal cannabis and the primary processing that is performed after harvesting. By confirming the best agricultural practices, this standard lays the foundation to produce safe and high-quality agricultural raw materials for pharmaceutical products. The GACP ensures that medicinal cannabis-based products meet the requirements of the pharmaceutical industry and international regulatory authorities regarding their cultivation and primary processing.

The cultivation of medicinal cannabis must be carried out in a controlled environment (greenhouses or indoor facilities), with each stage of the process following specific requirements outlined in the company’s documented system. Additionally, every action, from the procurement of raw materials/propagating material to harvest, drying, packaging, and transportation, must be recorded to monitor and ensure the quality and safety of the final products. By implementing the GACP certification, producers ensure that every stage of cultivation and primary processing follows specific requirements and specifications.

Why is GACP Certification Important?

The revision of legislation in many countries worldwide concerning the reclassification of cannabis and the recognition of its medicinal value, has led a significant number of businesses to engage in medicinal cannabis cultivation. With the growth of the pharmaceutical industry and the increasing demand for cannabis products, pharmaceutical companies require high-quality raw materials for the production of active pharmaceutical ingredients (APIs). The GACP certification is the reward to the efforts of those businesses to apply good agricultural practices and proves in the best possible way their compliance with the pharmaceutical industry’s requirements, while at the same time builds up trust between producers and buyers.

Benefits of GACP Certification

The GACP certification is mainly addressed to producers and businesses involved in the cultivation and processing of medicinal cannabis:

  • Quality Assurance

GACP certification guarantees that cultivation and primary processing follow good practices to ensure the consistent production of safe medicinal products that meet the pharmaceutical industry’s requirements.

  • Market Access

Compliance with GACP requirements allows medical cannabis producers to access markets where the strictest global requirements apply, such as Europe, Australia, etc. Pharmaceutical companies, adhering to Good Manufacturing Practice (GMP) guidelines, demand the application of specific techniques and specifications throughout the supply chain. Implementing a GACP-certified system demonstrates adherence to these requirements.

  • Competitive Advantage

Obtaining GACP certification differentiates the producer from its competitors and strengthens its credibility in international markets.

  • Process Improvement

Applying the GACP standard establishes the groundwork for a continuous improvement process, both for the system implemented by the producer, as well as for the product. Continuous improvement is a core requirement of every quality assurance standard, and GACP also leverages certification towards to support the need for ongoing improvement.

  • Increased Trust

GACP certification increases the trust of pharmaceutical companies and consumers in the products supplied by the producer/business, enhancing their reputation and credibility throughout the supply chain.

The GACP Certification Process

The certification process follows the following steps:

  • Preliminary Stage
  • Review of the client’s application: Determine the required audit time and audit team.
  • Scheduling the audit: Set audit dates.
  • Stage I of Certification Audit (Initial Certification)
  • Conducting the initial audit, either remotely or through an on-site visit to the production facility. During Stage I audit, an evaluation of the applicable legislation and regulatory documents and a check of the preparedness of the quality system is performed. Moreover, processes, equipment, and facilities are discussed with the auditee. Finally, any other element which ensures that the quality system has been installed and applied according to the standard’s requirements is reviewed.
  • Submission of conclusions/observations to the business.
  • Setting or adjusting the date of the on-site evaluation.
  • Stage II of Certification Audit
  • Sending the Audit Plan.
  • On-site inspection of the processes applied by the applicant, according to the requested certification scope by a Q-CERT auditor.
  • Filling out a non-conformance record form (if findings are present).
  • Submission of a corrective action plan and appropriate documentation of corrective actions from the business (where applicable). Evaluation by the inspector.
  • Preparation of the final report by the inspector and submission to Q-CERT for evaluation.
  • Final Stage
  • Review/evaluation of the inspection file by the relevant department/reviewer of the Certification Body.
  • Issuing of the certificate and dispatch of documents to the business.

For the Q GACP Certification Regulation please refer to Q-CERT.

Who should obtain GACP Certification for medical cannabis?

  • Target Audience


The GACP certification scheme for medicinal cannabis is applicable to all producers/businesses holding a relevant license from the competent authorities for cultivating cannabis for medicinal purposes. Although there are specific geographical zones, where cultivation is favored by the climatic conditions (day length, temperatures, etc.), the level of control achieved with high end equipment and suitable methods used by businesses worldwide, allows successful cultivation of cannabis plants nearly on every continent or area (from Argentina to Canada, South Africa to Denmark, as well as in Asia and Australia).

GACP certification is essential for producers/businesses aiming to ensure the quality and safety of their products and comply with international standards to compete in the global market. The certification provides producers with the ability to prove that the cultivation and primary processing of medicinal cannabis follow the best agricultural practices and the most stringent quality standards required by the pharmaceutical industry.

Special Needs of the Pharmaceutical Industry (EU GMP, GMP, TGA etc.)

The pharmaceutical industry requires strict compliance with quality standards for sourcing raw materials, such as the dried cannabis flower. Compliance with the GACP protocol is stipulated by Good Manufacturing Practice (GMP) guidelines, whether for producer is aiming at the European market (EU GMP volume 4, Annex 7), at Canada (Good production practices guide for cannabis), or Australia (TGA Herbal medicinal products, Annex 7). Companies must ensure GACP compliance either for their use (e.g., for further processing like oil production) or for export/sale to other trading or processing businesses in the pharmaceutical industry.

Additional Information

GACP certification for the cultivation and primary processing of medical cannabis is carried out based on the Q GACP standard developed by Q-CERT in 2020.

FAQs on GACP Certification

Can a small business obtain GACP certification?

Yes, the GACP certification is suitable for businesses of any size. Our Certification scheme flexibility allows its application to any kind of business, provided the producer has the necessary licenses as required by local/national law. However, it is important to note that only production units cultivating medical cannabis in a controlled environment (such as greenhouses or indoor facilities) can be certified. Regarding outdoor cultivation or non-permanent installations (e.g., net houses), Q-CERT does not accept and cannot approve applications for this method of cultivation due to difficulties in meeting the certification’s objectives and product quality/safety requirements.

How will GACP certification benefit my business?

The GACP certification provides a clear framework for implementing best practices in the cultivation and primary processing of medical cannabis, ensuring the quality and safety of the products produced. Q-CERT’s experience in this field stems from its long-standing expertise in international and national Good Agricultural Practices certification standards and its five-year experience in GACP certification for medicinal cannabis businesses. The GACP standard not only demonstrates compliance with GACP requirements but also contributes to the improvement of the system toward the stricter specifications of GMP.

Is GACP certification necessary to collaborate with pharmaceutical companies?

Ensuring GACP compliance is one of the main criteria that pharmaceutical companies require to guarantee the quality and safety of their raw materials. Certifying the cultivation and production process under GACP is the first significant step for a business wishing to supply medicinal cannabis as a raw material to pharmaceutical companies.

For more information or questions regarding Q GACP certification, you can contact Q-CERT.