Team · Qualified Person (QP) and Head of Quality Control
Dr. Kai Huwig
Qualified Person (QP) and Head of Quality Control
Key areas
What Kai is responsible for at A&O.
Dr. Kai Huwig is a Qualified Person (QP) under § 14 AMG and Head of Quality Control. He studied chemistry, holds a doctorate in the subject and acquired the expert knowledge required under § 15 AMG through a postgraduate pharmacy programme. He is responsible for QP batch release, analytical services, operational QM support and interim management. His technical focus is the validation of analytical methods.
As Qualified Person (QP) under § 14 AMG, Kai holds a role that the German Medicinal Products Act (AMG) requires to be filled by a named individual. This responsibility can neither be delegated nor shared across a team: it is their signature that releases the batch.
- Qualified Person under § 14 AMG
- Validation of analytical methods
- Head of Quality Control under the AMWHV
Education
Degree and doctorate in chemistry, postgraduate pharmacy programme to acquire the expert knowledge required under § 15 AMG
Responsible for 6 services
Case studies
Case studies from Kai's areas of work.
Anonymised projects from the services Kai is responsible for.
Mid-sized company in pharmaceutical research
Stored active substance tested and taken forward to an investigational medicinal product
A highly potent cancer active substance manufactured some time ago is to be used for an investigational medicinal product. We assessed its GMP complia...
Read the full case studyClinical trial sponsor, university hospital
Academic trial: placebo, analytical testing and QP release
A university hospital needed a medicinal product and a placebo for a trial in a new indication. We found the manufacturer, prepared the application, c...
Read the full case studyClinical trial sponsor, small biotech company
Non-EU active substance and investigational medicinal product released
The active substance and the investigational medicinal product are manufactured outside the EU. We oversaw GMP-compliant manufacture, audited the manu...
Read the full case studyClinical trial sponsor, biotech company
Comparator sourced, labelled and released
An authorised medicinal product was to serve as a comparator in a clinical trial. We oversaw its GMP-compliant sourcing and labelling and released the...
Read the full case studyInternational pharmaceutical services company headquartered in the USA with locations in the EU
Compassionate use programme: QP release
Patients were to receive a medicinal product not yet authorised for their indication. We oversaw its GMP-compliant transfer into the compassionate use...
Read the full case studyClinical trial sponsor, small innovative biotech company
Novel manufacturing process, supported through to phase 2a
A multi-stage manufacturing process with many manual steps was to be automated in compliance with GMP. The phase 2a trial went ahead, and production t...
Read the full case studyClinical trial sponsor, small biotech company
Third-country active substance: QP release for a clinical trial
Active substance from a non-EU country, investigational medicinal product for a trial in several European countries: we provided GMP oversight, the IM...
Read the full case studyClinical 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 studyLarge international pharmaceutical company
Method transfer and EU retesting for a third-country product launch
A marketing authorisation holder is planning to launch a medicinal product made in a non-EU country. We handle method transfer, EU retesting, import w...
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 studyMid-sized pharmaceutical company and marketing authorisation holder
Qualified Person (QP) and Head of Production provided
A marketing authorisation holder needed a Qualified Person (QP) for batch release and, for a period, a Head of Production. We provided both, and busin...
Read the full case studyMid-sized contract manufacturer of medicinal products
QP batch release after EU import for a Swiss contract manufacturer
A Swiss contract manufacturer needs batch release for its authorised medicinal products after import into the EU. We release every batch on an ongoing...
Read the full case studyClinical trial sponsor, innovative biotech company in cancer therapeutics
Recombinant protein from old stock made usable
A recombinant protein manufactured some time ago was to be used in an investigational medicinal product. We confirmed its GMP compliance and so create...
Read the full case studyThe whole company
