Case Study: Medicinal Cannabis Facility and GMP Compliance Engineering Project

Situation | Scenario: A global corporation sought to become a provider of medicinal cannabis products cultivated and processed in Australia, for two purposes: (1) to meet Australian domestic demand for medicinal cannabis and (2) for exportation into Europe. Hence, the designs and product needed to comply with the PIC/S Code of GMP, the strictest of international regulations namely the European Union (EU) GACP and Code of GMP and the German Pharmacopeia.

Medicinal Cannabis Facility and GMP Compliance

Project Scope including GACP and GMP Specifications

With future market expansion and early-market entry in mind, the client, Australian Natural Therapeutics Group (ANTG), sought assistance with the licensing, design and development of a facility which would meet Australian and European regulations for processing medicinal cannabis, including future exportation of pharmaceutical grade products.

Project specifications for PharmOut included architecture, engineering and facility designs and assisting with ODC/TGA licensing to enable ANTG to:

cultivate, dry and process medicinal cannabis for the Australian and international markets.
provide dried cannabis flowers as a final dosage form.
enable production and future exportation of medicinal cannabis products using a CO₂ extraction system, to meet future medicinal cannabis demands.

The Architecture, Engineering and GMP Facility Design scope included:

Facility designs/engineering and licensing to enable the company to cultivate, harvest, dry, cut and pack medicinal cannabis under GACP and GMP conditions.
A fully enclosed greenhouse for medicinal cannabis cultivation
Secure processing areas
An office area with staff amenities.

Project Stages and Implementation:

Australian Location 1: Growing and processing facility design including architecture and HVAC design
Australian Location 2: Processing facility including storage (vault area) and drying facilities
Support during procurement, construction and commissioning.

OCD / TGA licensing

GMP and ODC licensing for both locations

Licenses | Medicinal Cannabis Facility and GMP Compliance

Cannabis Facility Licenses Required

The medicines were going to be marketed in Australia and Europe.
The facility required a TGA license to manufacture therapeutic goods in the future.
The Code of GMP is PIC/S Guide to Good Manufacturing Practice.

Solution

PharmOut followed a ‘staged’ approach to executing the project based on ISPE Good Practice Guide: Project Management for the Pharmaceutical Industry.
- Stage 1: Flower production and processing (10g final dosage form)
- Stage 2: Medicinal cannabis production (extraction, purification, capsuling and packaging) including office building requirements.
- Stage 3: Facility and licensing
Preliminary designs were provided initially, followed by detailed designs after client approval; PharmOut also handled PQS, URS and validation documents.

Outcome: TGA Manufacturing Licensing for both Part 1 and 2 of the GMP code.

“Going through the Australian licensing and facility engineering processes for producing medicinal cannabis, including for future exportation to Europe, was far more complex than anticipated. However, our medicinal cannabis cultivation and processing facilities are now fully compliant with ODC/TGA licensing requirements and all international regulations, including EU GMP. We are well-positioned to meet growing market demands for medicinal cannabis in Australia and overseas.” Matt, CEO of ANTG

ANTG medicinal cannabis EU-GMP Facility case study

Deliverables: Preliminary Designs

Deliverable	Comment
Scope definition	· Basis of design
Architectural preliminary design	· Site layout · Room layouts · Material, equipment, personnel flow diagrams
Mechanical preliminary design	· Zone and classification diagrams · Pressurisation diagrams · Air schematics · Preliminary ductwork layouts · Plant layouts · Preliminary equipment sizing

Deliverables: detailed design deliverables

Deliverable	Comment
General support detailed design	· Technical support for process and workflow development · General support through different industries
Architectural detailed design	· Room layouts (Revit) · Sections · Material, equipment, personnel flow diagrams (Revit) · Architectural fit out specifications (Location 1) · Architectural specifications (Location 2)
Mechanical detailed design (Location 2)	· Air schematics · Ductwork layouts · Pipework layouts · Details drawings · Technical specifications · Equipment schedules · Mechanical services switch board (MSSB) schedules · Direct digital control (DDC) points schedules
Design risk management/design qualification	· Design review