Quality Assurance and Quality Control

Our Quality Assurance and Quality Control Department is responsible for 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. 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 physical appearance of the product and packaging, certificate of analysis supported by a risk based additional product analysis for pharmaceuticals not originating from the EU. The process of quality control / Quality Assurance is supervised by our QP.

Good Manufacturing Practise

Amstelfarma has built up close relationships with a number of leading European suppliers All our supliers have to 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 QP 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 products sold by Amstelfarma. These product files hold the following pharmaceutical information:

• specific Amstelfarma 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 to you on request.