The Medical Export Group (MEG) has a fully-incorporated quality system to ensure a constant level of services and products, including both pharmaceuti-cals and medical devices. MEG has been authorised since 1995 by the Dutch Authorities to act as a pharmaceutical wholesaler.
Quality management system
Our quality management system is built on four foundations:
The entire quality management system may result in an approved status for a supplier. This status is monitored regularly, and ranking can change according to the supplier’s performance on orders, results of re-analysis of pharmaceuticals, regular site audits or information received from the market. Our ISO 9001-2008 certification helps us continuously improve our business processes and enables us to anticipate the dynamic needs of our customers. All aspects of our business are laid down in Standard Operating Procedures (SOPs) enabling us to work efficiently as well as accurately.
One of the key focus points of our Quality Assurance department is vendor prequalification. All suppliers of pharmaceuticals and medical devices have to be prequalified by our QA department. All potential new sources have to fill out a prequalification questionnaire, which is thoroughly screened. All pharmaceutical manufacturers must comply with the guidelines of Good Manufacturing Practice (GMP). Furthermore the manufacturing site, registration and marketing status of each product is thoroughly investigated. Apart from these documentation controls, the finished products are randomly tested at an independent laboratory to assess compliance with their product specification. This process is clearly described in our document Monitoring the quality of pharmaceuticals, a copy is available on request.
For medical devices, MEG underlines the guidelines as stipulated by the Global Harmonization Task Force and the EU directive (Council Directive 93/42/EEC of 14 June 1993 concerning medical devices). Although the manufacturer is responsible for the classification of its products and compliance with the specifications, MEG has classified all its medical devices according to the possible risk and vulnerability for the human body. The classification is laid down in our computer system on a product basis and quality controls are carried out accordingly. Products with a classification III are considered as the most critical products. For these products each manufacturing site must be approved by our Quality Assurance department and CE marking must be present for all products. Apart from this documentation, random (sterility and other) testing is performed by an independent laboratory to assess product compliance.
The Quality Control department is involved with the physical control of the incoming goods and the documentation control of all batches. Analytical controls that comply with the monographs of either the British or United States Pharmacopeia, carried out by an independent laboratory, are part of the quality controls. The laboratories must underline the guidelines of Good Laboratory Practice (GLP) and are prequalified by the World Health Organization (WHO).
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Good Distribution Practice guidelines (G.D.P., Directive 92/25/EEC) are adhered to, in order to ensure that the quality of our products is maintained throughout the entire distribution network. Should we ever need to initiate a recall, a track and trace system is part of this certification enabling us to track each and every shipment within 24 hours. The temperature in our warehouse is closely monitored and, from 2010, MEG will also be measuring relative humidity to guarantee that our products are stored in accordance with the products specifications. A cold storage room enables MEG to store products between +2 and +8 degrees Celsius and narcotics are kept in our safe.
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Since our services and quality depend heavily on the quality and performance of our suppliers, we carefully select and screen all suppliers and their products. To be able to support our customers in their global relief programmes, MEG needs to deliver a broad range of products. Currently we have a product range of over 7,000 different items, bought from approximately 350 active suppliers. Our database for potential suppliers is even more extensive. Based on the intensive partnerships we have with our suppliers, we are able to deliver a complete spectrum of products.
We are constantly sourcing for new, close relationships with manufacturers of pharmaceuticals and non-pharmaceuticals such as hospital equipment, disposables and medical equipment etc. MEG only procures products from prequalified sources. This qualification is set in close cooperation between our QA and procurement departments.
Our prequalification covers the following steps:
- If applicable, assessment of site and supply chain
- Vendor-rating and audits on-site