Designing for the TGA and EU GMP Medicinal Cannabis Standards
It is well known that the TGA and EU GMP Medicinal Cannabis requirements demand a high level of product quality. Knowing this, we consulted with PharmOut to ensure that we would be able to comply while also factoring in the most economical way to grow medicinal cannabis in an Australian environment.
PharmOut are known as world leaders in TGA and EU GMP-compliant pharmaceutical and medicinal cannabis facility design, and their growers, consultants and engineers have helped numerous companies across with globe with their plans to produce medicinal-grade products for domestic use and/or exportation to global markets.
Avoiding common mistakes
Murray Meds has avoided the mistakes being made by many international companies investing in Australia. Typically these companies have “picked up and dropped” models deployed by the parent company back in their own countries. In assessing optimum cultivation strategies for Australian conditions it is imperative to:
a) consider the Australian climatic conditions, and which medicinal cannabis strains grow best
b) assess the costs involved with Australian energy, water, and employee wages
c) appreciate the local TGA GMP regulatory requirements for medicinal cannabis (and the costs of setting up and maintaining a GMP licence)
Insufficient consideration of these factors resulted in many of these businesses investing in indoor facilities without realising the substantial additional overhead costs. While there are advantages to indoor facilities (e.g. environmental controls), the capital and operational costs mean that products will be much more expensive for the patients.
Due to the unfavourable economics of an indoor grow there is a growing global trend towards closure of indoor facilities, as cultivators shift to outdoor grows, even in countries with far less suitable climatic conditions.
Designing in Quality
PharmOut factored in the strict TGA and EU GMP medicinal cannabis requirements right from the outset while also helping us design a cultivation strategy that would be both economical and comply with the Office of Drug Control security guidelines:
1. We criticality assessed site location, climate controls and lighting considerations (including humidity, heating, cooling, watering, optimal Daily Light Integral) before the site was selected.
2. We decided to adopt a broadacre cultivation strategy as even though there are initially higher security perimeter costs. This is more than offset by fact that sunlight is free. Having a lower carbon footprint also aligns with our core values.
3. We conducted extensive research into regulations because we knew we had to comply with the strict TGA regulations, the Therapeutic Good Orders (TGO 93 and TGO 100), ODC security guidelines, Good Agricultural and Collection Practice (GACP) and the demanding German Pharmacopoeia requirements. This included reviews of factors which directly impacted the product, e.g. cultivation and crop protection, incoming materials, employee health and hygiene, etc. as well as broader work areas such as security systems, storage, waste management, transportation and distribution.
4. To help with the extensive record-keeping requirements, we have incorporated a cloud-based Pharmaceutical Quality System (PQS) which is fully compliant with TGA and EU GMP medicinal cannabis regulations.
5. To optimise and minimise errors in personnel and material flow we used cutting edge 3D rendering and visualisation tools to completely visualise the facility before construction. This also allowed for more efficient design reviews.
6. We have had an independent security risk assessment performed of the facility and perimeter and have implemented comprehensive risk mitigation procedures and implemented state of the art security systems.
All these measures as well as ongoing internal processes built into our Pharmaceutical Quality System (PQS) such as internal audits, deviations, change control, corrective and preventative actions, etc. ensure that we are able to keep track of, and control over our critical quality and security parameters and to consistently deliver TGA and EU GMP medicinal cannabis products to our local and global customers.