From lab to GMP production
Having grown out of development, the GMP structure is often missing. It must be in place before you produce and release.
Industry · Manufacturers & Biotech
GMP quality management for manufacturers and biotech.
From development to manufacturing: we build a GMP-compliant quality system with you in good time – whether your own production or contract manufacturing, including a Qualified Person (QP).
Starting point
From active ingredient to approved manufacturing.
Biotech and development companies reach the same point: at the latest for manufacturing, GMP structures are needed – built before the first batch is produced.
In-house or contract manufacturing
Both routes require clear quality responsibility, clean interfaces and robust agreements (QAA / technical agreement).
Qualified Person (QP)
The Qualified Person – as the responsible expert under §14 AMG – needs clearly assigned responsibility and lived release processes.
Services
We build your GMP QM – and support the rollout.
- GMP QM system build – structures, processes and document hierarchy from the ground up.
- SOPs & documentation – created, controlled and clearly worded in line with GMP.
- Qualified Person (QP) – as the responsible expert under §14 AMG: advice, coaching or taking on the role.
- Contract manufacturing – selection, qualification and quality assurance agreements (QAA).
- Qualification & validation – facilities, processes and computerised systems to GAMP 5.
- Hands-on support – active collaboration on QM topics, not just concepts on paper.
Approach
To a GMP-ready structure in four steps.
- Status assessmentClarify development stage, timeline to manufacturing and requirements.
- Structure & strategyDefine in-house vs. contract manufacturing, roles and the QP model.
- Build & documentationCreate the QM system, SOPs and specifications and put them into force.
- Rollout & supportIntroduce processes, enable the team, support up to the GMP inspection.
Consultation
Planning the step into manufacturing?
The earlier the GMP structure is in place, the smoother the path to the first batch. We tell you what needs to be done now.