Further down the line, however, in its manufacturing facilities – in the pharma "kitchens" – the industry is still mired in the mid-20th century.1 Computer technology's spread has stalled at machine-level data collection for tracking basic processing information. The pharma industry has lagged in using IT on a broader scale to automate and streamline time-consuming manufacturing processes, specifically its batch record systems and for maintaining process quality control. Limited automation, electronic record keeping, and information collection contribute to pharma's poor manufacturing efficiency record — and to a costly and increasingly crippling regulatory reporting infrastructure. Pharma industry equipment utilization hovers below 40 percent, which would be an unacceptable figure in most industries.2 Industry statistics for batch quality failures range from 5 to 15 percent.3 As a comparison, the semiconductor market — which dealt with similar process problems 25 years ago — today, has waste significantly below one percent.4
Pharma manufacturing's primary efficiency issues are:
Electronic batch record (EBR) and process analytical technology (PAT) information systems are key elements of a new paradigm in pharmaceutical manufacturing to eliminate these inefficiencies and transform manufacturing processes from a liability into an asset for meeting regulatory and market demands. EBR and PAT systems can create a common data framework that turns plant floor data into a strategic-level tool. The information they generate can help production managers increase yield while helping analysts and executives root out inefficiency, plan capacity usage, and meet regulatory reporting requirements without digging through stacks of paper that manual batch record systems generate.