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 Medicinal Products Act (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.

Further Awards

We were audited by Qualifyze on behalf of a customer and were awarded Gold status as a pharmaceutical supplier as part of the Quality Compliance Programme.