New toolkit to assist drug quality assurance
to help pharma companies improve manufacturing quality assurance
Analysts at Best Practices have compiled the toolkit based on several recent studies with 10 of the top 20 pharma companies.
It is designed for executives in the pharma industry who oversee quality control and assurance and are looking to the tools of benchmarking and best practices to find opportunities for savings and efficiency gains in the R&D function, said the firm.
Included in the package are research documents on quality assurance staffing and use of risk-based approach programmes; case studies in risk-based approach programs; driving quality excellence - key industry challenges and lessons learned; and best practices in quality structure.
Drug companies face significant risks if the quality of their product does not comply with government regulations and several major firms have been forced to close manufacturing facilities in recent years due to failed Food and Drug Administration (FDA) inspections - a very costly exercise.
In 2004, vaccines giant Chiron was forced to shut down its facility in Liverpool, UK, and cease production of its Fluvirin flu vaccine after serious production problems as a result of contamination were discovered.
The company also had to write off the entire Fluvirin vaccine product inventory in the third quarter of 2004, resulting in a $91m (€71m) charge to cost of sales.
In order to avoid disasters such as this, quality assurance leaders face the challenge of when and where to audit the manufacturing process.
According to researchers at Best Practices, many have now adopted a risk-based approach to help them determine which manufacturing facilities are more likely candidates for errors, and should be proactively monitored for defects before FDA reviews.
"There was a case where I was sure a sample was not usable. The material had been outside [a designated area]. It was expensive and there was a lot of time pressure but I was pushed to make a decision, initially, I said, 'no,' since we always take the conservative path," one executive director of R&D Quality Assurance told a Best Practices analyst.
"However, a formal risk analysis showed there was very little risk and we were able to use it safely. This saved us about $50,000 on the cost of the drug. Also we would have missed a window on the study. That would have cost much more."