Pharmacovigilance & QP services
QP services

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 services

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.

Quality management

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.