PIC/S GMP-Compliant PQS for a Greenfield Medicinal Cannabis Manufacturer

Supporting the Development of a GMP a Greenfield Facility

A first-of-its-kind facility, a Schedule 8 controlled substance, and a quality system built from the ground up ahead of the client's first TGA inspections.

  • Client: Greenfield medicinal cannabis manufacturer based in Victoria, Australia

  • Sector: Medicinal cannabis manufacturing — extraction, bulk supply and finished dose forms

  • Project type: Greenfield QMS build, QA/CMC support, laboratory systems development and eQMS transition

  • Standards: PIC/S GMP • TGA licensing & TGO93 requirements • Poisons Standard (Schedule 8) controls

  • Outcome: QMS built from the ground up and proven across the client's first two TGA site inspections, followed by a transition to a Veeva eQMS.

The Challenge

Our client was a new medicinal cannabis manufacturer building a greenfield facility from scratch, combining super-critical CO2 extraction, bulk bottling for pharmacy compounders, and fill/finish of bottles, vaps and soft gel capsules under one roof. None of this could run without a Pharmaceutical Quality System (PQS) behind it, and none existed yet — QSN was brought in to build the PQS and provide hands-on QA and CMC support to a team of company staff who were themselves being onboarded as the facility came together.

The facility introduced compliance demands beyond a typical GMP build. Cannabis is a Schedule 8 controlled drug, requiring dedicated processes for its secure receipt, storage, movement and reconciliation, including use of an on-site vault. A new analytical laboratory — equipped with HPLC, GC, GC-MS, AAS and general wet chemistry apparatus — needed its own quality processes from the ground up. And the whole system had to be ready to stand up to real scrutiny: the client's TGA licensing site inspections.

Our Approach

QSN worked alongside the client's own engineering, production and technical teams throughout the build, developing systems and processes in step with the facility itself rather than retrofitting them once operational.

Core PQS

  • Built the facility's core PQS from the ground up, including doc management, training, deviations, CAPA, change control, complaints, manufacturing and production processes, batch review and release for supply.

  • Developed processes for equipment and facility management, working directly with the company's engineer

  • Developed CMC-related processes, including production, managing reference and retention samples, distribution and disposition.

  • Supported the development of the stability programme.

  • Supported the validation of manufacturing equipment with protocol development and review, and VMP development.

Cannabis and Facility Processes

  • Developed processes governing the receipt, storage, movement and reconciliation of cannabis as a Schedule 8 controlled drug, including use of the facility's on-site vault.

  • Built processes to support the facility's extraction, bulk bottling and fill/finish operations across bottles, vaporisers and soft gel capsules.

Laboratory Systems

  • Developed laboratory processes for the client's new analytical laboratory, covering equipment including HPLC, GC, GC-MS, AAS and general wet chemistry tehniques.

  • Developed processes for laboratory data checking and data integrity, release of results, batch review and release for supply.

Training Support and eQMS Transition

  • Provided ongoing QA and CMC support to company staff onboarded throughout the facility's development.

  • Delivered all-hands training across the PQS, PIC/S GMP awareness, data integrity and Good Documentation Practice, and TGO93 and the regulatory requirements of the Office of Drug Control (ODC).

  • Supported the client's transition to a Veeva eQMS at the end of the project, including executing the vendor's User Acceptance Testing (UAT) scripts and supporting computer systems validation (CSV) activities and reporting.

  • Supported the client through their first two TGA site licensing inspections and their 2 year follow-up inspection.

The Outcome

  • A PQS built from the ground up across a first-of-its-kind extraction, bulk supply and fill/finish facility in Australia.

  • Fit-for-purpose processes in place for the secure handling of a Schedule 8 controlled drug, including on-site vault management

  • A fully operational quality system for the client's new analytical laboratory, supporting HPLC, GC, GC-MS, AAS and wet chemistry testing

  • The client successfully supported through their first two TGA site licensing inspections and 2-year follow up GMP inspection.

  • A smooth transition to a Veeva eQMS, with QSN executing the vendor UAT scripts and supporting CSV as part of go-live.

"With Kathy involved in the project, I would expect the PQS to be excellent." — remark made by the attending TGA inspector to the client's QA Director, during the facility's first site inspection

Building a first-of-its-kind facility?

Whether you're establishing a greenfield GMP facility, building quality systems around controlled substances, or preparing for your first regulatory inspection, QSN can help you get there.

Check out our relevant services - Site Licensing and Accreditation, Regulatory Compliance and Auditing or QMS.

Or check out our retainer options for Audit4Life and Compliance4Life.