Quality management benchmarking: FDA compliance in pharmaceutical industry.
OBJECTIVE
By analyzing and comparing industry and business best practice, processes can be optimized and become more successful mainly because efficiency and competitiveness increase. This paper aims to focus on some examples.


METHODS
Case studies are used to show knowledge exchange in the pharmaceutical industry. Best practice solutions were identified in two companies using a benchmarking method and five-stage model.


RESULTS
Despite large administrations, there is much potential regarding business process organization. This project makes it possible for participants to fully understand their business processes. The benchmarking method gives an opportunity to critically analyze value chains (a string of companies or players working together to satisfy market demands for a special product).


CONCLUSIONS
Knowledge exchange is interesting for companies that like to be global players. Benchmarking supports information exchange and improves competitive ability between different enterprises. Findings suggest that the five-stage model improves efficiency and effectiveness. Furthermore, the model increases the chances for reaching targets. The method gives security to partners that did not have benchmarking experience.


CONCLUSIONS
The study identifies new quality management procedures. Process management and especially benchmarking is shown to support pharmaceutical industry improvements.
Institute for Industrial Science and Process Management, University Kassel, Kassel, Germany. jochem@ifa.uni-kassel.de
Roland
R
Jochem
Katja
K
Landgraf
D019985:Benchmarking; D004345:Drug Industry / Q000458:organization & administration* / Q000592:standards; D019983:Guideline Adherence / Q000458:organization & administration* / Q000592:standards; D017408:Guidelines as Topic; D006801:Humans; D019982:Organizational Case Studies; D011785:Quality Assurance, Health Care / Q000458:organization & administration* / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration