Quality Management (ISO & cGMP certification)

It is Saltigo´s policy to consistently supply our customers with high quality products and services which meet their needs and comply with regulatory requirements and company standards.

This is documented in our HSEQ policy.

ISO certification

Saltigo is certified according to the ISO certification standards 9001 and 14001.

In April 2009 we were recertified according to ISO 9001:2008 and 14001:2004. Our latest ISO certificate can be found here.

Besides these we hold further certificates for products, plants or sites 
(e.g. ISO 17025, QS 9000/TS16949, cGMP, OHSAS 18001).

cGMP certification

The cGMP facilities in Leverkusen (D) and Redmond (USA) operate under a cGMP-system, which is based on international Guideline ICH Q7A and is approved by the FDA and German Authorities.

Our latest cGMP certificate was issued by the German Authorities in 2009.

The Saltigo cGMP-Handbook describes the fundamental quality elements of our QA system for the development, production and control of APIs and their intermediates, and our policies regarding these quality elements. These policies define the basic requirements of the GMP-related activities of Saltigo and its affiliates, and are applicable to both development and commercial products.

Responsibility for implementing, maintaining and enforcing these policies is with a dedicated Quality Assurance organization (QU-API) within Saltigo.

Based on our track record and expertise, and in close cooperation with you, our customers, we can apply an adequate level of cGMP compliance to serve your needs from clinical development through to product launch.

We employ established and validated cleaning methods depending on development stage and your requirements.

Customers and authorities (FDA and German authorities) audit our facilities on a regular basis.