Team · Qualified Person (QP) and Head of Production
Dr. Thomas Lutz
Qualified Person (QP) and Head of Production
Key areas
What Thomas stands for.
Dr Thomas Lutz is Qualified Person (QP) under § 14 AMG and Head of Production under AMWHV. The pharmacist, who holds a doctorate in pharmaceutical chemistry, is also the responsible person for wholesale distribution under § 52a AMG, Graduated Plan Officer (Stufenplanbeauftragte) under § 19 Abs. 7 AMWHV and person responsible for narcotics. He advises on GMP and GDP, oversees quality management and sterile manufacturing, and prepares for and follows up on regulatory inspections. His work has included the testing of a stored active substance for a clinical trial, a method transfer with an EU retest, and stepping in at short notice as the person responsible for narcotics.
As Qualified Person (QP) under § 14 AMG, Thomas holds a role that the Medicines Act (AMG) requires by name. This responsibility can neither be delegated nor spread across a team: it is on the paper that releases the batch to the market.
- Qualified Person under § 14 AMG
- Head of Production under AMWHV
- Responsible person for wholesale distribution of medicinal products under § 52a AMG
- Graduated Plan Officer (Stufenplanbeauftragte) under § 19 Abs. 7 AMWHV
- Person responsible for narcotics
- Quality management
- Sterile manufacturing and compounding
- GMP and GDP consulting
- Preparation, accompaniment and follow-up of regulatory inspections
Education
Degree in pharmacy, licence to practise as a pharmacist, doctorate in pharmaceutical chemistry
Responsible for 5 services
Case studies
Case studies from Thomas's areas.
Anonymised projects from the services for which Thomas is responsible.
Sponsor of clinical trials, small biotech company
Active substance from a third country, release for the clinical trial
A sponsor without its own QP needed GMP oversight for manufacture in a non-EU country, the IMPD and release of the investigational medicinal product,...
Read the full case studySponsor of clinical trials, small biotech company
From the IMPD to release, all from a single source
Active substance manufacture in a non-EU country, formulation development, analytics and QP release: a project combining almost all of our services.
Read the full case studyLarge international pharmaceutical company
Method transfer and EU retesting for launch from a third country
Analytical method transfer to our laboratory, EU retesting, import and warehousing with a logistics partner. Launch planned for 2027.
Read the full case studyInnovative biotech company in the field of cancer therapeutics
Establishing a GMP manufacturing facility for peptide vaccines
A renowned research institution is setting up a manufacturing facility for personalised peptide vaccines, we support them from regulatory affairs thro...
Read the full case studyMid-sized company. Marketing authorisation holder and pharmaceutical entrepreneur
Qualified Person (QP) and Head of Production provided
Following a personnel shortage, our appointed persons secured batch release and the QM system, and business operations continued without interruption.
Read the full case studyMedium-sized company. Contract manufacturer of medicinal products
Batch release after EU import for a Swiss contract manufacturer
Continuous release of commercial medicinal products following import into the EU, plus advice on changes and operational QM support.
Read the full case studyThe whole company
