Vendor qualification for pharmaceutical excipients--GMP requirements and approach.

Excipients are, in the large majority of cases, not made specifically for pharmaceutical use. Most pharmaceutical excipient manufacturers supply less than 10% of the total production of that particular material for pharmaceutical use. Excipient product portfolio consists of hundreds of products differing in chemistry, origin and functionality and they are used in many different applications. The days of treating excipients like commodities and buying them without fully qualifying the source and the entire distribution chain have gone by as GMP regulations demands to ensure quality of other materials used in the manufacturing process. The paradigm that exists in some pharmaceutical companies today where excipients are sourced from distributors without knowing the actual manufacturer, manufacturing site and full distribution lifecycle chain to be changed. The present contribution gives an overview about the current moves on GMP requirements for pharmaceutical excipient and approach for qualification of pharmaceutical excipient manufacturers.