Quality and QP services
HWI is a GMP-certified company and has its own manufacturing authorisation for batch releases of medicinal products, investigational medicinal products and veterinary medicinal products as well as an import authorisation.
EU batch releases
Batch releases, including batch certifications according to EU GMP Annex 16, are offered by a Qualified Person (QP) of HWI according to your requirements via the following services:
- Batch releases by a Qualified Person via the manufacturer's authorisation from HWI
- Function as an external Qualified Person in your company
We take over your batch releases for finished medicinal products (human and veterinary), investigational medicinal products (IMP) as well as biological medicinal products (biologicals), including sterile dosage forms.
Through our import authorisation, we also fulfil the requirements according to Annex 21 of the GMP guidelines and can support you with the import and EU release of your products.
Monday - Friday