Team · Qualified Person (QP) and Head of Quality Control
Dr. Kai Huwig
Qualified Person (QP) and Head of Quality Control
Key areas
What Kai stands for.
Dr Kai Huwig is Qualified Person (QP) under § 14 AMG and Head of Quality Control. He studied and holds a doctorate in chemistry and attained the expert knowledge required under § 15 AMG through further education in pharmacy. He is responsible for batch release, analytical services, operational QM support and interim management. His area of technical focus is the validation of analytical methods.
As Qualified Person (QP) under § 14 AMG, Kai 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
- Validation of analytical methods
- Head of Quality Control under AMWHV
Education
Degree and doctorate in chemistry, further education in pharmacy to attain expert knowledge under § 15 AMG
Responsible for 4 services
Case studies
Case studies from Kai's areas.
Anonymised projects from the services for which Kai 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 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 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
