Locations · Itzehoe · GMP laboratory in the north
Analytics and 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 our own manufacturing and import authorisation on site. Test results and release come from a single source.
53.92° N · 9.52° E
For testing and EU retesting
From method transfer to the released batch.
For medicinal products from third countries, EU law generally requires full testing of each batch in the EU before a Qualified Person certifies it. In Itzehoe, both happen side by side: the analytics in our own laboratory and the release. That saves handovers and time. 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 Section 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 management and a Qualified Person work side by side.
Regulatory affairs, consulting and further Qualified Persons are based at our headquarters in Efringen-Kirchen. All sites work as one team, under one phone number.
- Laboratory
- GMP-certified and fully digitalised
- Analytics
- HPLC, GC, LC-MS/MS, IR and UV-Vis spectroscopy, dissolution
- Key areas
- EU retesting, nitrosamines, biotech medicinal products, cannabis
Team in Itzehoe
Who tests and releases your samples.
Authorisations and certificates
Ready to read, no request needed.
Career
Open positions in Itzehoe.
Getting here
Itzehoe
A&O Pharma GmbHc/o IZET Innovationszentrum
Fraunhoferstraße 3
25524 Itzehoe
Itzehoe
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