Transforming drug production with digitalised “just-in-time” manufacturing
The pharmaceutical industry’s reliance on “just-in-case/build to stock” manufacturing often leads to high waste—up to 60%—and inefficiencies through human-QC checking of manual GMP steps. To address this, the PACE (Pharmacy Automation for Clinical Efficiency) project revolutionised drug production by developing an innovative, make-to-order automated multi-product packaging capability, with automated GMP and digitalised JIT QA/QP certification.
Developed through an ambitious collaboration, which included Centre for Process Innovation, Sewtec Automation, AstraZeneca, GSK, and other key stakeholders including systems development from Siemens, project management support from MOAT and digital GMP innovation from QMSPharma. The result: a fully operational prototype that integrates cutting-edge hardware, innovative software, and automated digital processes to deliver precision, efficiency and compliance.
The PACE Line: A Game-Changer in digitalised JIT Production
Key achievements of the PACE platform include:
- Concurrently processing multi-arm clinical orders (e.g., active/placebo/comparator) on the same packing line.
- Unique patient-targeted in-line automated label printing with camera verification of the full label mask.
- Digitally verifying registration, GMP, and PQS data to enable real-time batch certification.
- Delivering patient-centric batch sizes as small as a single bottle— from IRT order, fill, label and certify capability in hours vs days.
- Significant reduction in waste through automated digital verification.
Addressing Industry Pain Points
The innovation project identified that traditional QA/QP processes involve human verification of over 1,500 data points across over 23 systems, consuming valuable time and increasing error risks. This innovation reduced manual checks by 80%, enabling error-free GMP verification and dramatically improving process efficiency.
The project identified that maximum waste reduction/sustainability in human-managed manual processes can only achieve minimum 50% waste reduction; only with automation can this go lower, through digital automation and in-line verification steps.
Delivering Industry 4.0 in Pharma Manufacturing
PACE redefines Just-In-Time pharmaceutical production by combining automation, digitisation, and flexibility to meet patient needs sustainably and with enhanced GMP controls, automated data extraction and verification processes. It’s a bold step towards embracing Industry 4.0, proving that innovation, when expertly managed, can transform traditional models into efficient, future-ready systems.
The move from concept to project innovation through to PACE becoming a commercial reality has shown what cross-industry collaboration can achieve – a step-change in pharmaceutical quality improvement.