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.
For 29 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 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 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.
HWI regulatory services GmbH is certified according to DIN EN ISO 9001:2015. Our quality-management system is a key pillar to ensure we provide our customers with high-quality services and is certified by TÜV SÜD Management Service GmbH every three years.
We are regularly inspected by our customers (corporations and medium-sized companies)..
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“.
The Planegg/Martinsried site has also been certified according to DIN EN ISO 9001 since 2015.
HWI pharma services GmbH
Phone: +49 7272 7767-2517
Dr. Alexandra Keilbach-Bermann
HWI development GmbH
Phone: +49 7805 401-502
Dr. Tanja Köllmeier
HWI regulatory services GmbH
Phone: +49 89 2000203-82
Monday - Friday
08:00 - 17:00 o´clock