quality management (QM)

We provide comprehensive consultancy services for meeting the requirements of quality management according to the German Drug Law (AMG), Ordinance on the Manufacture of Medicinal Products and Active Substances (AMWHV) and EU-GMP and EU-GDP-guidelines.

In detail, we offer you our support in the:

  • establishment of your quality management system (including pharmacovigilance)
  • review and maintenance of your quality management system
  • application for manufacturing, import and/or  wholesale linceses release testing and stability testing
  • batch release by a Qualified Person of HWI
  • planning and performance of GMP-/GDP-audits and self-inspections
  • interface for the cooperation and communication with authorities
  • adoption of duties of responsible persons (Qualified Person, EU-QPPV, Graduated Plan Officer (“Stufenplanbeauftragter”),  Information Officer (“Informationsbeauftragter”))

Contact: Dr. Inge Unsöld, Project Management V&Q
Email: i.unsoeld(at)hwi-group.de
Phone: +49 7272 7767-2538

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