The second stage of certification audit and compliance of Galenika a.d. operation with international standards ISO 9001:2008, ISO 13485:2003/MDD 93/42 and HACCP system was successfully completed.
Audit of our integrated QMS was performed by the eminent German auditing company TÜV SÜD from 21 to 24 April, 2009. Based on the audit report, it was proposed that Galenika a.d. be issued a certificate.
The certificate will be issued for DEVELOPMENT, MANUFACTURING AND SALES OF MEDICAL AND DIETARY SUPPLEMENTS and COMMON USE PRODUCTS.
- Audit confirmed that:
- the entire operation and manufacturing of medicinal products at the Drug Plant was in compliance with ISO 9001:2008 standard requirements,
- the manufacturing o medical devices at the Dental Plant and Parapharmaceuticals Plant was in compliance with ISO 13485:2003/MDD 93/42 standard requirements, which gave us the right to put CE marking on them,
- the manufacturing of dietary supplements at the Parapharmaceuticals Plant was in compliance with HACCP system requirements and Good Hygiene Practice.