Locations · Itzehoe · GMP laboratory in the north
Testing and batch release under one roof.
In Itzehoe, our GMP-certified laboratory tests medicinal products, active substances and starting materials, and a Qualified Person releases the batches under the site's own manufacturing and import authorisation. Test results and batch release come from one provider.
53.92° N · 9.52° E
For testing and EU retesting
From method transfer to released batch.
For medicinal products from third countries, EU law generally requires full testing of every batch in the EU before a Qualified Person certifies it. In Itzehoe, both happen in one place: testing in our own laboratory and batch release. That means fewer handovers and less time lost. Exceptions apply to products from countries with a mutual recognition agreement (MRA) that covers them, for example Switzerland, the USA, Canada or Israel. There is no such agreement with India, China, Turkey or Taiwan.
- 01 Release testing and EU retesting to your specification
- 02 Method transfer, validation and method development under GMP
- 03 Trace analysis by triple quadrupole LC-MS/MS, for example for nitrosamines
- 04 Batch release by a Qualified Person under § 14 AMG
Our site in the north
At the Itzehoe innovation centre, near Hamburg.
Our laboratory is located at the IZET Innovation Centre Itzehoe, about 50 kilometres north-west of Hamburg as the crow flies. Here, the Head of Quality Control, the laboratory manager and a Qualified Person work side by side.
Regulatory affairs, consulting and other Qualified Persons are based at our headquarters in Efringen-Kirchen. All sites work as one team, reachable on one phone number.
- Laboratory
- GMP-certified and fully digitalised
- Techniques
- HPLC, GC, LC-MS/MS, IR and UV-Vis spectroscopy, dissolution
- Key areas
- EU retesting, nitrosamines, biotechnology-derived medicinal products, medicinal cannabis
Team in Itzehoe
Who tests your samples and releases your batches.
Authorisations and certificates
Download directly, no request needed.
Directions
Itzehoe
A&O Pharma GmbHc/o IZET Innovationszentrum
Fraunhoferstraße 3
25524 Itzehoe
Itzehoe
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