What is the Biotech Baseline Guide all about?
For many years, the pharmaceutical industry has experienced a ratcheting effect in the cost of new facilities. This increase in cost has been driven in part by uncertainty about the requirements for regulatory compliance. The absence of a consistent and widely accepted interpretation of regulatory requirements has led to creeping incrementalism. This practice of discretionary investment in plant features that are neither required nor indicated has led to increased cost, longer lead times and, in many cases, delays in bringing new products to market. In May 1994, engineering representatives from the pharmaceutical industry engaged in a discussion with the International Society for Pharmaceutical Engineering (ISPE) and the Food and Drug Administration (FDA). That first discussion led to a plan to create a family of 12 facility engineering Guides, now known as the BASELINE Pharmaceutical Engineering Guides®. In November 1994 the ISPE sanctioned the beginning of this important project and
