Essential drugs are purchased by IDA, preferably from generic drug manufacturers who produce the raw materials and the finished dosage forms, and from contract manufacturers. It has approximately 120 approved suppliers. In practice, the majority of purchases is obtained from 60 suppliers. The number of products supplied by IDA is about 300. The main source countries are Austria, Belgium, China, Denmark, France, Germany, India, Italy, Mexico, Portugal, South Korea and UK. IDA also has a manufacturing plant in Malta, PHARMAMED, which manufactures tablets and dry syrups. The plant supplies some 20% of IDA's turnover. Products of PHARMAMED are not registered in the Netherlands.
The actual suppliers are selected through a supplier pre-qualification process. There is a group of suppliers who have provided IDA with pharmaceuticals of an appropriate quality for a long time and who are considered reliable. New suppliers are asked to produce documentary evidence that they are licensed by the local drug regulatory authority and furnish a GMP certificate delivered by this authority. On review of these documents, a decision is made whether an on-site audit is necessary. In 1993, some 30 such audits were made according to a "Manufacturer Audit Check-List" established internally by IDA. During the audit, the stability data on products offered by the manufacturer are also reviewed. The costs of the audit are borne by IDA. On the basis of the results of the audit, a decision is made whether to approve the new supplier.
Qualification of manufacturers is followed by qualification of individual products offered by them. This process includes the following: the supplier is asked to provide samples of his products. These samples are analyzed at the IDA laboratory in Amsterdam, or if more complex testing is necessary, sent to an external laboratory, usually the laboratory of Dutch pharmacists. Specifications are next established for the product, usually the British Pharmacopoeia (BP) or USP are used.
For the BP specifications, the dissolution test is frequently added. If a product is not included in these pharmacopoeias, the manufacturer's specification is used, but after review and approval by the IDA laboratory. For some products, the IDA laboratory has evolved its own quality specifications, which include bioequivalence testing. In 1992, some 300 new and revised product specifications were approved. All products bear the name of the manufacturer on the label.