Information Management Systems Enable Manufacturing Facilities to Ramp Up Productivity

Reporting requirements and safety regulations make reliable IT systems a high priority at the manufacturing level.
Sep 01, 2005
Volume 18, Issue 9

The pharmaceutical industry has a record of making good use of technology in product development, most notably for replacing "wet" research with computer databases that enable researchers to test many combinations of chemical or biological compounds in simulated environments. This computerized research has improved product development's pace and efficiency exponentially as companies face increasing pressure to put more products in the pipeline.

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:

  • Poor process understanding and control, which causes lower yields and production delays due to subsequent quality control procedures5
  • Inefficient, voluminous, paper-based production workflow, which produces very slow set up, production, verification, etc.6
  • Chronic uncertainty of demand in the consumer market.7

Dave Femia
These factors are a recipe for supply-chain inefficiency that has yielded average inventory turns of three to five versus 50 for world-class manufacturers in other industries.8

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.

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