At long last, the report that our magazine (and the industry's manufacturing professionals) have been waiting for, from Jackson Nickerson at Washington University of St. Louis and Jeffrey Macher of Georgetown, benchmarking data on drug manufacturing, obtained by detailed surveys and studies of 42 drug manufacturing facilities.
We'd been hounding both professors for over a year, but the study took a little extra time to complete, not surprisingly given secrecy of this industry.
What they found wasn't all that pretty, but may lead to significant change.
Interestingly enough, the study suggests, manufacturing decisions appear to improve, the lower down the "chain of command" one goes. Those doing the work, when trained and empowered, can make the biggest difference in results, a lesson that more drug companies are slowly learning. Findings may also have some implications for pharmaceutical process analytical technologies (PAT) programs.
- 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 -- has 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 Nickerson. In fact, process analytic technology may improve a drug's quality. However, the F.D.A. 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 F.D.A. 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.
