Team · GMP Consulting and Training
Alexander Trautmann
GMP Consulting and Training
Key areas
What Alexander is responsible for at A&O.
Alexander Trautmann is a licensed pharmacist and is responsible for GMP consulting and training at A&O Pharma. He works in strategic GxP consulting, operational QM support and interim management. His areas of focus are GMP training, support during regulatory inspections and pharmaceutical production, as well as ISO 13485, MDR and IVDR. He also covers vaccines, in vitro diagnostics and food supplements.
As Head of Production, Alexander ensures that medicinal products are manufactured and stored in accordance with the regulations and approves the manufacturing instructions. The German Ordinance on the Manufacture of Medicinal Products and Active Substances (AMWHV) requires this position to be independent of quality control.
- GMP consulting
- GMP training
- ISO 13485, MDR and IVDR
- Regulatory inspections
- Pharmaceutical production
- Vaccines, in vitro diagnostics, food supplements
Education
Licence to practise as a pharmacist
Responsible for 4 services
Case studies
Case studies from Alexander's areas of work.
Anonymised projects from the services Alexander is responsible for.
Clinical trial sponsor, small biotech company
From IMPD to QP release, all from a single provider
A new active substance from a non-EU country was to be used in a phase 1 trial as an investigational medicinal product. We provided GMP oversight, pro...
Read the full case studyInnovative biotech company in cancer therapeutics
Setting up a GMP manufacturing facility for peptide vaccines
A research institution is setting up a GMP manufacturing facility for personalised peptide vaccines. We are supporting it from regulatory classificati...
Read the full case studyThe whole company
