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Quality assurance

Our Quality Assurance and Quality Control Departments are responsible for the continuous evaluation and approval of both the manufacturers and the specific products of each manufacturer. The approval of manufacturers is based on detailed review of the relevant documentation combined with site inspections by our responsible pharmacists. The approval of products is based on a detailed review of a full product dossier, while the actual release of each batch is based on the physical appearance of the product and packaging. An additional certificate of analysis supported by an extra product analysis for each batch originating from China or India. The process of quality control / Quality Assurance is supervised by our pharmacists.

GOOD MANUFACTURING PRACTISE

KNS Holding B.V has built up a close relationship with several leading European suppliers. All our suppliers must comply with GMP (Good Manufacturing Practice) standards and must provide us with a Manufacturing License as well as an extensive Site Master File, a detailed QA questionnaire and in general are inspected by our pharmacists before they will be approved. All manufacturer files and specific product files are kept up to date by our Quality Assurance Department.

PRODUCT FILES / PHARMACEUTICAL CERTIFICATES

Our Quality Assurance Department also maintains detailed files on all our sold products. These product files hold the following pharmaceutical information:

Specific Product Questionnaire

CPP (Certificate of Pharmaceutical Product) or FSC

(Free Sales Certificate)

Composition

Stability data

Example of label

Leaflet

Certificate of Analysis (example)

A copy of relevant product information from these product files can be sent upon request.