Our quality management system ensures that the identity, efficacy and quality of every product are maintained right through to delivery.
Wholesale authorisation for human medicinal products, issued by the competent state authority.
Certified quality management for the distribution of medical devices.
Connection to the national verification system for authentication.
Systematic risk assessment, CAPA and annual external audits.
The QMS comprises organisational structure, procedures, processes and resources to safeguard medicine quality along the entire distribution chain — described in a binding QM manual to GDP.
Risks are systematically identified, assessed and minimised (based on ICH Q9), at least annually and as the occasion requires.
Deviations, complaints and audit observations are recorded, root-cause analysed and assigned actions, owners and deadlines — including effectiveness checks.
At least annual self-inspection, supplemented by an annual external GDP audit by an independent auditor.
All records are attributable, legible, contemporaneous, original, accurate as well as complete, consistent, enduring and available.
Are you authorised to purchase under §47 AMG or active internationally in the regulated healthcare market? Get in touch.
Sanicura Medical GmbH
Weissacher Straße 10 · 01623 Lommatzsch · Germany
+49 (0) 35241 – 87 01 07
wholesale@sanicura-medical.com
Purchasing authorisation is verified before first delivery.
