When a competitor withdrew a drug from the market, Novartis AG raced to capture market share. To beat the competition, each link in the company’s supply chain had to hold fast under grueling time pressure.
Novartis Ringaskiddy Limited (NRL) is an important link, responsible for turning raw materials into the bulk active pharmaceutical ingredients (API) in Novartis medicines. For this project, NRL had to launch and validate a new production process for a key API.
The new process was among the most complex ever introduced at NRL in terms of chemistry and equipment. Added to this was a crushing schedule. It takes several weeks to produce the API used in this drug.
When the first batch was completed, the quality was to specification but the quantity was below target yield. The yield problem had to be fixed quickly in order to ensure supply to links further up the chain.
NRL was prepared for the challenge. Over 100 employees had been trained in Kepner-Tregoe Analytic Trouble Shooting® (ATSSM). They use this common tool and language to specify, analyze, and ultimately, solve problems. This project would seriously test their skills.
Program Leader Pat O’Sullivan facilitated a multi-functional troubleshooting team of process chemists and engineers, the plant manager, the production supervisor, and an expert consultant on the new process. Sharing a strong commitment to resolving the yield problem, the team followed the systematic ATS process using data from a variety of sources including manual and electronic batch records and trends, development reports, and production shift logs. The problem was solved, and “fixes” were made. When the first fixed batch was completed several weeks later, it met standard yield. Validation was completed in record time.
The supply chain held. Novartis beat the competition to market, increased market share, and sales boomed, increasing 20%. The yield problem has never recurred.