• Quality management

Quality management

For more than 30 years we have been providing services of the highest quality, as quality is our first priority.

The HWI group works under regulatory supervision in accordance with the provisions of GMP and GVP in pharmacovigilance. We consistently implement GMP and the associated provisions of the German Ordinance for the Production of Medicinal Products and Active Substances (AMWHV) and of the EU good manufacturing practice (GMP) guidelines.

Regular inspections every three years verify compliance with official requirements. We continuously adjust our quality-management system to the latest regulations and regularly gain additional professional skills from internal and external training.

We also collaborate with external experts and review our quality-management processes frequently to detect potential for improvement.

We view our customer audits as an opportunity to continuously develop our quality-management system and to discuss matters with quality officers of medium-sized companies and international corporations.

 

HWI pharma services GmbH

HWI pharma services GmbH has the manufacturing authorisation for batch release according to section 13, paragraph 1, of the German Drug Law (AMG). We also meet the cGMP requirements in the US.

In 2018 the US supervisory authority the FDA (Food and Drug Administration) conducted a successful inspection of our Ruelzheim site and we were listed by them as an accepted testing laboratory.

 

 

HWI development GmbH

HWI development GmbH is also GMP-certified and has a manufacturing authorisation according to section 13, paragraph 1, of the German Drug Law (AMG). It includes the manufacture and quality control of oral solid dosage forms with active ingredients up to OEB class 4.

Audits at a glance

Customer audits

Customer audits per year

We are regularly inspected by our customers (corporations and medium-sized companies)..

  • 2016: 21 Ruelzheim Site / - Appenweier Site
  • 2017: 13 Ruelzheim Site / 3 Appenweier Site
  • 2018: 14 Ruelzheim Site / 4 Appenweier Site
  • 2019: 17 Ruelz­heim Site / 5 Ap­pen­wei­er Site
  • 2020:   9 Rülzheim Site / - Appenweier Site
  • 2021: 11 Ruelzheim Site / 4 Frankfurt Site / 2 Appenweier Site

FDA inspections

FDA inspection

From 26th to 27th November 2018 the inspection was performed at HWI’s Rülzheim site by the US Food and Drug Administration (FDA) with
the result „no observations – no action indicated“.

GMP inspections

GMP inspections

HWI pharma services GmbH

  • Ruelzheim 1st GMP inspection 1998
  • Ruelzheim: 28.07.2004
  • Ruelzheim: 11.09.2007
  • Ruelzheim: 11.11.2010
  • Ruelzheim: 11.12.2013
  • Ruelzheim: 09.11.2016
  • Ruelzheim: 26.09.2019
  • Frankfurt: 12.11.2020

HWI development GmbH

  • 20.01.2009
  • 30.01.2012
  • 19.-20.11.2013
  • 14.06.2016
  • 08.05.2019

 

Manufacturing authorisation

Manufacturin Authorisaton

At all 3 sites, we have permission to manufacture and release of clinical test samples and small market batches,

Audits at a glance

With just a few clicks on the circles, you can find out how many customer and official audits have taken place in the past few years.

 

Kathrin Wagner
Quality Management
HWI pharma services GmbH

Phone: +49 7272 7767-2517
Email:

Dr. Alexandra Keilbach-Bermann
Quality Management
HWI development GmbH

Phone: +49 7805 401-502
Email:

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Hotline

Monday - Friday

+49 7272 7767-0