Batch release services

Product description

Quality Management

Thanks to our experience and profound knowledge of quality management, we provide comprehensive advice and support in meeting the requirements of quality management according to the German Drug Law (AMG), ordinance on the manufacture of Medicinal Products and Active Substances (AMWHV) as well as EU-GMP and EU-GDP guidelines.
 
In detail, we support you in:
  • Compilation, implementation and management of a quality assurance system (including pharmacovigilance system)
  • Review and maintenance of your quality management system
  • Application for manufacturing, import and wholesale licences
  • Planning and performance of GMP/GDP audits and self-inspections
  • Interface for the cooperation and communication with authorities
Batch Release for Medicinal Products
We possess a manufacturing authorisation for batch release according to section 13 (1) of the German Drug Law (AMG).

We provide the following services:
  • Batch release by a Qualified Person from HWI
  • Adoption of responsibility as external Qualified Person
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