Combining Lean Manufacturing with GMP compliance

The situation

Using Lean Manufacturing methodologies, PharmOut helped a pharmaceutical company in Australia identify laboratory testing as a bottleneck in their manufacturing process. Final product was being held up in the in-process warehouse for as long as 3 weeks, waiting for the lab results.

The solution

PharmOut recommended that the company invest in new instrumentation that complied with the FDA's, Process Analytical Technology (PAT) guidelines. This would reduce the load on the QC laboratory and remove the bottleneck.

The results

With the PAT instrumentation in place, the company was able to reduce the time that the product sat in the warehouse by 2 ½ weeks. This improved their manufacturing cycle time considerably.