• Vigilance & Quality
  • Quality management/batch release

Quality management

We provide consultation on how you can fulfil quality management requirements according to the German Drug Law (AMG), the German Ordinance for the Production of Medicinal Products and Active Substances (AMWHV), and EU GMP and GDP guidelines.

We undertake the following functions for you:

  • Set-up of your QM system (incl. pharmacovigilance)
  • Review and maintenance of your QM system
  • Application for a manufacturing, import and/or wholesale authorisation
  • Preparation and follow-up of inspections and audits
  • Quality control (batch release and stability testing)
  • Batch release by a qualified person at HWI
  • Planning and execution of GMP/GDP audits and self-inspections
  • Interface in the cooperation and communication with the authorities
  • Takeover of functions of the responsible person (qualified person, EU-QPPV, Stufenplanbeauftragter graduated plan officer)

Batch release

HWI is GMP-certified and has its own manufacturing authorisation for the release of market and clinical batches of medicinal products.

On this basis we offer the following services:

  • Batch release by a qualified person at HWI
  • Taking on the responsibility as an external qualified person for your company

 

Dr. Inge Unsöld
Qualified Person

Phone: +49 7272 7767-2538
Email:

Contact us. We’re happy to help!

Hotline

Monday - Friday
08:00 - 17:00 o´clock

+49 7272 7767-0