Responsibilities and practicalities for testing pharmaceutical software-bridging the gap

Pharmaceutical manufacturers are required under good manufacturing practice (GMP) regulations to “validate” their software systems. Perhaps the best known GMP regulations exist in the United States and the European Union and are policed by the US Food and Drugs Administration (FDA) and UK Medicines Control Agency (MCA). Failure to satisfy national regulatory authorities can lead to the delay, non-issue or withdrawal of a pharmaceutical manufacturer´s licence to market a drug product in a given country. Validation is a business critical issue. The problem comes when pharmaceutical manufacturers and suppliers endeavour to understand each other´s perspective, expectations and limitations. This paper explores these issues and their practical resolution