The researchers collected data from 42 manufacturing facilities owned by 19 manufacturers. Their analysis revealed five key outcomes that influence the pharmaceutical manufacturing performance metrics.
Information Technology. Companies that used IT to electronically and automatically report, track and resolve deviations; track people; and centrally store all data, uniformly displayed superior manufacturing performance compared to those without such IT.
Decision making. The lower down in the ranks that companies allow employees to make decisions, the higher the overall manufacturing performance. This is especially true when considering deviation management, lot failure, lot review and process valuation.
Outsourcing. Contract manufacturing generally – although not always – have inferior manufacturing metrics.
Process analytic technology. The use of technology that measures the uniformity of a drug’s content prior to the completion of the final product, corresponds to worse performance measures. The correlation doesn’t imply causation, said Jackson Nickerson, professor of organization and strategy at the Olin School of Business at Washington University in St. Louis. In fact, process analytic technology may improve a drug’s quality. However, the Food and Drug Administration (FDA) had been encouraging the industry to adopt use of the technology using the argument that it would improve overall performance. Nickerson said, this finding may cause the FDA to rethink their reasons for endorsing process analytic technology.
Size and range. The scale and scope of the manufacturing facility have a complex interplay with manufacturing performance. Depending on what aspect of manufacturing is being measured, scale and scope can either be a detriment or a benefit.
MEDICA.de; Source: Washington University in St. Louis