Following a successful inspection by the Regional Council (Regierungspräsidium) of Tuebingen, Germany, BioChem Labor für biologische und chemische Analytik GmbH obtained, in addition to the GMP confirmation, the Manufacturer’s Authorisation for

• human medicinal products and human investigational medicinal products acc. to § 13 AMG and
• veterinary medicinal products acc. to § 28 TAMG and (EU) 2019/6

This refers to the microbiological, chemical/physical and biological quality control for medicinal products, raw and starting materials, active pharmaceutical ingredients and packaging materials.

All certificates are available for download in the Public Layout of the EudraGMDP database and on our homepage in the downloads section.

BioChem is pleased to offer its clients now a variety of services through the own QP (Sachkundige Person/Qualified Person acc. to § 15 AMG), Ms Clarissa Kohn. This new QP service optimally complements BioChem’s wide range of analyses:

• Confirmation of quality control by QP
• Storage of retention samples acc. to § 18 AMWHV and Annex 19 GMP guideline
• Consulting of clients on obtaining their own manufacturer’s authorisation
• Further consulting services, e.g., on GMP topics and regulatory requirements on request

In our brochure „Manufacturer’s Authorisation and QP service”, these services are summarised (please click here for download).