Frequently asked questions

A module is a self-contained, qualified GMP manufacturing unit on the GMPLEX™ campus. Each module has its own HVAC, environmental monitoring, utilities and airlocks so it can run independently of neighbouring operations. Modules are where product is made — dispensing, processing, packing and in-process control.

A suite is on-site office and administrative space, kept separate from manufacturing areas. Suites house leadership, quality, regulatory, planning and commercial teams working on or alongside the campus, with meeting space and secure document handling. In short: modules are for making products, suites are for people and paperwork.

Yes. They are licensed separately. Some partners take a module and keep their corporate office elsewhere, and others take a suite first to place quality and regulatory staff on campus while still manufacturing through the OUTSOURCE pathway. Most partners end up with both as their operation matures.

Modules are sized around your process train and batch size rather than a fixed floor plate, and adjacent modules can be linked or added as volume grows. Because the campus infrastructure and quality system are shared, adding a module is a controlled expansion rather than a new site build.

GMPLEX™ offers four manufacturing pathways that let you start where you are and scale as you grow. OUTSOURCE: we manufacture for you under our licence and quality system. COLLABORATE: you own the product and process while we provide the people, systems and oversight. OPERATE: you lead your dedicated module on campus with GMPLEX™ process quality systems and shared services behind you. CONTROL: you run your own qualified module and quality system, supported by the campus infrastructure. Move between pathways as your process, volume and maturity evolve.

The right pathway depends on where you are in your product lifecycle, how much control you want, and how ready your organisation is to hold GMP responsibility. Early-stage companies and those validating their process often start with OUTSOURCE or COLLABORATE. As volumes become predictable and teams grow, partners move into OPERATE or CONTROL. We map your process, volumes and regulatory position to a recommended pathway during our first technical call.

Yes. The pathways are designed as a continuum. Because the quality system, utilities and campus infrastructure stay consistent, moving from OUTSOURCE to COLLABORATE, OPERATE or CONTROL is treated as a controlled change within the same GMPLEX™ ecosystem rather than a site transfer. This protects your regulatory filings and supply continuity while you scale.

The backup house is surge and contingency manufacturing capacity retained on the GMPLEX™ campus. Use it when your own line is down, demand spikes, or you need a second-source batch without qualifying a new contract manufacturer. Access is reserved for pathway partners and tenants on agreed terms, and it remains available after you move into your own GMP space.

Most partners start with GMPLEX™ warehousing and distribution: GMP-compliant ambient storage, quarantine, release, picking and Australia-wide distribution. You only take on your own warehouse when your volume makes it economical, and you can keep using GMPLEX™ warehousing as backup or overflow after you do.

Validated cold rooms (2–8 °C and controlled-temperature options) are part of the shared backbone. Tenants and owned-space partners book space by pallet or shelf with continuous environmental monitoring and alarm escalation, so you do not need to build and qualify your own cold-chain storage early on.

Under OUTSOURCE and COLLABORATE, GMPLEX™ holds the licence and the quality unit carries GMP release responsibility. Under OPERATE, you lead the module with GMPLEX™ process quality systems and shared services behind you. Under CONTROL, you hold your own authorisations, with the campus quality framework, utilities and monitoring supporting your system through defined interfaces and agreements.

The campus is designed and documented to PIC/S GMP standards and TGA expectations, covering qualification and validation, environmental monitoring, data integrity, change control, deviation and CAPA management, and audit readiness. Documentation packs are available to partners under confidentiality.

Most partners reach commercial supply through the OUTSOURCE pathway within 12–18 months of signing, depending on technology transfer and validation. Moving into COLLABORATE, OPERATE or your own CONTROL module usually follows once the process is stable and demand predictable, often in the 24–36 month range, and the timeline flexes either way.

No. Because the quality system, utilities and campus infrastructure stay consistent, moving from OUTSOURCE to COLLABORATE, OPERATE or CONTROL is treated as a controlled change within the same GMPLEX™ ecosystem rather than a site transfer. Filings and supply continuity are managed through the same quality unit and change-control process.

Yes. Scale never outruns support. Even after you graduate to your own building you retain access to the backup manufacturing house, warehousing, cold rooms, shared utilities and the campus technical ecosystem on commercial terms.

The campus is built for oral solid dose and related non-sterile forms, with capability from pilot and scale-up batches through to commercial production runs, plus packaging and serialisation-ready finishing. Talk to us about your dosage form and volumes and we will map them to the right pathway.

Send an enquiry through the contact form with your product type, target volumes and timing. A short technical call follows, then we issue an indicative pathway and pricing outline. To move to proposal we typically need your process description, specifications, bill of materials and any existing regulatory dossier under confidentiality.

The first 90 days are structured around scoping, proposal, quality and technical transfer, and first compliant batch. Week 1–2 covers fit and module mapping; Week 3–5 delivers a costed proposal; Week 6–9 runs quality agreements, documentation and tech transfer; Week 10–13 completes validation and the first batch under the GMPLEX™ quality system.

We typically ask for your process description, specifications, bill of materials, analytical methods, existing regulatory dossier and any current quality agreements. The exact list is tailored to your pathway and product type, and we provide a checklist at the start of onboarding.

Change control, deviations, CAPAs and documentation updates are managed through the GMPLEX™ quality system. Partners receive defined interfaces and escalation paths so that changes are assessed, approved and closed with full traceability and audit readiness.

Yes. The first commercial or registration batch is manufactured under full GMP once module qualification, method transfer and required validation are complete. Earlier engineering or trial batches are clearly separated and labelled in the project plan.

Not initially. Under OUTSOURCE and COLLABORATE, GMPLEX™ carries the quality unit and release responsibility. Under OPERATE you lead the module with GMPLEX™ Process quality systems behind you. Under CONTROL you hold your own authorisations, supported by the campus infrastructure and defined quality interfaces.