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Team · Qualified Person (QP) under § 14 AMG

Dr. Klaus-Peter Kreth

Dr. Klaus-Peter Kreth

Qualified Person (QP) under § 14 AMG

Licence to practise as a pharmacist, doctorate in pharmaceutical analytics, specialist pharmacist for pharmaceutical analytics

Key areas

What Klaus-Peter stands for.

Dr Klaus-Peter Kreth is Qualified Person (QP) under § 14 AMG, heads Quality Control and is Head of Production under AMWHV. He holds a licence to practise as a pharmacist, has a doctorate in pharmaceutical analytics and is a specialist pharmacist for pharmaceutical analytics. He is responsible for strategic GxP consulting, operational QM support and interim management. As an auditor, he prepares for, accompanies and follows up on regulatory inspections.

As Head of Production (AMWHV), Klaus-Peter 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.

  • Quality management
  • Operational QA
  • Preparation, accompaniment and follow-up of regulatory inspections
  • Auditor

Education

Licence to practise as a pharmacist, doctorate in pharmaceutical analytics, specialist pharmacist for pharmaceutical analytics

Responsible for 4 services

Regulatory Affairs Marketing authorisation, iMAH and Life Cycle Management, from strategy to variation Strategic GxP Consulting & QA Support Validation, qualification and GxP audits, so quality remains predictable Operational QM/QA Support CAPA, deviations, PQR and supplier qualification, handled operationally Interim Management Statutory responsibilities, staffed at short notice with qualified personnel

Case studies

Case studies from Klaus-Peter's areas.

Anonymised projects from the services for which Klaus-Peter is responsible.

Sponsor 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 study

Innovative 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 study

Mid-sized company, marketing authorisation holder

Manufacturing site transfer: CMC review, transfer plan and support

Review of the marketing authorisation chapters and quality documents, risk assessments and a robust transfer plan for the planned change of manufactur...

Read the full case study

The whole company

More specialists at A&O Pharma.

Dr. Olaf Mundszinger Dr. Olaf Mundszinger Founder and Managing Director Ute Hegener Ute Hegener Regulatory Affairs Dr. Barbara Siebertz Dr. Barbara Siebertz Regulatory Affairs Alexander Trautmann Alexander Trautmann GMP Consulting and Training Leidy Fajardo Leidy Fajardo Risk Assessment and GMP Documentation

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