Turn Key Medicinal Cannabis design and compliance

Holistic and turn key medicinal cannabis facility design.

Holistic and turn key medicinal cannabis facility design.

Turn key medicinal cannabis design and compliance

6 stage gates during the project

6 stage gates during the project

PharmOut offers a turn key medicinal cannabis design and compliance service as we have a full range of compliance, architectural and engineering services, and by working closely with our clients, we offer a full turn key medicinal cannabis design and compliance service. We provide guidance and advice from the start of your medicinal cannabis journey and by working closely with you we can leverage off our existing compliance and design pharmaceutical skills to ensure we fully specify your facility.

We use the industry recognised standard from the International Society of Pharmaceutical Engineers for our Project Management methodology, provide 6 clear go / no go stages in all our engineering projects. We use Building Information Modelling (BIM) and 3D to help everyone visualise the facility by walking through the facility before the concrete is even poured.

Through engaging a holistic digital engineering methodology, PharmOut designs medicinal cannabis facilities from first principles and allows you to visualise all aspects of your process.

“Form follows function” within a lean facility design approach, with the layout being driven inherently by the process flows and intrinsically achieving the GMP objective of unidirectional flow.

For example, the facility design above provides for 12 series of sequenced modules, the adjacency of which directly reflects the process steps. The resultant ‘U-shape’ flow provides for a singular point of facility control as the product moves from an inward receiving warehouse through growing, drying, manufacturing and packaging, and returning commonly to the secure vault and outward dispatch. In doing so, key factors such as security, product diversion and cross-contamination risks are significantly reduced, as part of a collective strategy of risk mitigation that is ‘designed into’ the layout.

PharmOut offers a full turn key facility design, either bespoke to your rural setting or from our library of standard drop-in designs. We can design the facility head house and grow house in indoor cultivation or traditional greenhouse environments.

Turn Key Medicinal Cannabis Facility Design

Turn Key Medicinal Cannabis Facility Design

The next set of slides will depict important aspects of a medicinal cannabis facility design which PharmOut as an experienced Architectural, Engineering, GMP and Engineering consultancy is unquestionably well equipped to help.

The facility design above reduces the security risk by having a single entry, this also embraces lean principles and achieves the GMP objective of unidirectional flow, an important cross contamination risk mitigation strategy.

The next set of slides will depict important aspects of a medicinal cannabis facility design which PharmOut as an experienced Architectural, Engineering, GMP and Engineering consultancy is well equipped to help.

The next few slides explains the advantages of a U shaped facility design and the GMP prerequisite unidirectional material flow.

Our compliance services include TGA GMP compliance and clinical trail services.

Useful TGA links

https://www.tga.gov.au/access-medicinal-cannabis-products-1

https://www.tga.gov.au/sites/default/files/manufacture-medicinal-cannabis-supply-under-approved-access-provisions.pdf

https://www.tga.gov.au/publication/manufacture-medicinal-cannabis-supply-under-approved-access-provisions

https://www.tga.gov.au/book-page/multiple-laws

https://www.tga.gov.au/book-page/manufacturing-principles

https://www.tga.gov.au/book-page/specific-aspects-relating-manufacture-and-scheduling-medicinal-cannabis

https://www.tga.gov.au/book-page/further-technical-gmp-guidance

https://www.tga.gov.au/book-page/related-guidance-and-further-information