GMPLEX™ Managed Manufacturing
Your product. Your expertise. Our GMP infrastructure.
Managed Manufacturing gives companies greater involvement and control while using GMPLEX™ facilities, infrastructure, equipment and specialist support. Your team can work alongside GMPLEX™ personnel, with services such as manufacturing support, QA, QC, equipment access and batch release available as required.
More control, without the capital cost of going it alone.
What's included
A flexible service model — take on as much or as little of the operation as suits your team, with GMPLEX™ covering the rest.
Facility & equipment access
Scheduled access to qualified GMP manufacturing areas, process equipment and utilities without capital investment.
Your team on the floor
Your technical and operations staff work alongside GMPLEX™ personnel, trained and inducted to site systems.
Manufacturing support
Operator support, changeover, cleaning verification and production planning provided at the level you need.
QA & QC services
Access to GMPLEX™ quality systems, in-process and release testing, deviation handling and documentation control.
Batch release
Optional release by GMPLEX™ authorised persons, or support for release under your own quality system.
Warehousing & cold chain
Ambient and temperature-controlled storage, quarantine, sampling and dispatch with full traceability.
Best suited to
- Companies moving beyond traditional CDMO outsourcing
- Growing production programs with recurring campaigns
- Businesses wanting greater control over their manufacturing process
- Teams that have technical capability but don't want to build their own GMP facility
How engagement works
- 01
Scope & feasibility
Product, dosage form, volumes, equipment fit and quality responsibilities.
- 02
Responsibility matrix
Agree exactly which activities sit with your team and which with GMPLEX™.
- 03
Onboarding & training
Site induction, SOP alignment and training for your personnel.
- 04
Technology transfer
Process transfer, engineering and validation batches under GMP.
- 05
Routine campaigns
Scheduled production, release and continuous improvement support.
Ready to take more control of your manufacturing?
Start with GMPLEX™ CDMO, step into Managed Manufacturing, and move to your own Dedicated GMP Module when you're ready.