• Pharmacovigilance & QP services
  • QP services

Quality and QP services

HWI is a GMP-certified company and has its own manufacturing authorisation according to §13 German Medicinal Products Act (AMG) for batch certifications of medicinal products, investigational medicinal products and veterinary medicinal products as well as an importer authorisation (MIA) according to § 72 AMG.

QP services and pharma consulting: our services

As part of our QP services and our pharmaceutical consulting, we offer you comprehensive monitoring and assurance of product quality in accordance with the Good Manufacturing Practice (GMP) guidelines and the specific requirements of § 13 AMG. This paragraph regulates the manufacturing authorisation for medicinal products and is an essential part of the legal requirements that we take into account in our quality control processes.

With many years of experience and comprehensive expertise in the field of pharmaceutical consulting, we develop tailor-made solutions that are precisely customised to your needs. Our interdisciplinary quality team will be pleased to advise you on batch releases, import, your QM system and demarcation 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 release / QP services

The QP service covers professional services provided by Qualified Persons. In the pharmaceutical industry, Qualified Persons (QP) verify that the manufacturing, import, testing and release of medicinal products is carried out in accordance with the EU Good Manufacturing Practice (GMP) guidelines and other relevant regulatory requirements.

We offer you batch release including batch certification according to EU GMP Annex 16 by our Qualified Persons (QP) according to your requirements via the following services:

  • Batch release by a Qualified Person based on the manufacturer authorisation according to § 13 AMG from HWI
  • Taking over the function as an external Qualified Person in your company

We take over your batch release/certification for finished medicinal products (human and veterinary), investigational medicinal products (IMP) as well as biological medicinal products (biologicals), including sterile dosage forms. Through our importation authorisation according to § 72 AMG, we also fulfil the requirements according to Annex 21 of the GMP guidelines and can support you with the importation and EU release of your products.

Quality management (QM)

Today, a functioning quality management system is required by law for every pharmaceutical company. We are ready to support and advise companies in the pharmaceutical industry in these matters or take over the following functions:

  • Set-up, review and maintenance of your QM system
  • Application for a manufacturing/importation authorisation (MIA) and/or wholesale distributor authorisation (WDA)
  • Interface in the cooperation and communication with authorities
  • Participation, preparation and follow-up of inspections
  • Performance, preparation and follow-up of GMP/GDP audits
  • Supplier qualification, evaluation of third-party audits, QP declarations
  • Performance, preparation and follow-up of self-inspections
  • Preparation and review of quality assurance agreements and delimitation agreements
  • Processing of complaints, quality defects and returns
  • Functions of responsible persons (Qualified Person, QM representative, Responsible Person according to Good Distribution Practice (GDP) guidelines)

Consulting on demarcation from other product groups and borderline products

Our experts are on call to provide you with competent advice. We support you concerning the classification of your products and their demarcation of other product groups such as food, cosmetics, medical devices or consumer goods.


Contact us. We’re happy to help!

Dr. Inge Unsöld
Qualified Person

Phone: +49 7272 7767-2538

Dr. Frank Böttcher
Qualified Person

Phone: +49 7272 7767-0

Dr. Stefan Wissel
Qualified Person

Phone: +49 7272 7767-0


Monday - Friday

+49 7272 7767-0