Our quality management system (quality manual consisting of SOPs and related documents) is based on EU-GMP Guidelines, Part II, with reference to distribution.
It covers the following items:
- Organisation and Responsibility
- Change Control
- Regulatory Affairs
- Entry Control and Batch Release
- Handling of Complaints
- Storage Condition Control
- Suppliers Assessment including Evaluation Criteria
- Supplier Auditing and Follow-up
- Personnel Training
All our staff-members work towards endorsing the GMP, to ensure that only the highest quality is obtained.
It’s our first aim to manifest and extend our high quality in customer service, great selection of materials and substances and to be completely conform with the regulations for the substances we deal with. This means above all the regulations for the Good Manufacturing Practices (GMP) and other pharmaceutical guidelines (ICH, WHO etc.).
For this purpose we established in our quality management system the following basic principles:
- Everyone is everywhere responsible for the quality of our work
- In all our activities the request and wishes of our customers come first
- In all steps of our activities we ensure complete and reliable tracebility
- We respect the regulations for our activities and products
- We accept our responsibility for our customers, our industry-partners and the community
- All quality related complaints will be recorded and investigated until full satisfaction for the customer is realized
- All important documents (CoS, DMF) should be available for all substances and kept up to date
It is a task for everyone to build and live our quality management system.