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.
Our interdisciplinary team will be pleased to advise you on batch releases, your QM system and differentiation issues and support you in fulfilling the requirements of the German medicinal products act (AMG), the German veterinary medicinal products act (TAMG), the German regulation for the production of medicinal products and active substances (AMWHV), the German Ordinance on the trade in medicinal products (AM-HandelsV) as well as EU GMP and GDP guidelines.
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.
Today, a functioning quality management system is required by law for every pharmaceutical company. We are ready to support and advise you in these matters or take over the following functions for you:
- Set-up, review and maintenance of your QM system
- Application for a manufacturing, import and/or wholesale licence
- Interface in the cooperation and communication with authorities
- Participation, preparation and follow-up of inspections
- Implementation, preparation and follow-up of GMP/GDP audits
- Supplier qualification, evaluation of third-party audits
- Implementation, preparation and follow-up of self-inspections
- Preparation and review of quality assurance agreements
- Processing of complaints and returns
- Functions of responsible persons (qualified person, QM representative)
Demarcation from other product groups, borderline products
Our experts advise you on the classification of your products and their demarcation from other product groups such as food, cosmetics, medical devices or consumer goods.
Dr. Jasmin Schweikert
Phone: +49 7272 7767-2524
Contact us. We’re happy to help!
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