Lean Pharmaceutical Consultants – Combining lean manufacturing with GMP

Lean Pharmaceutical Consultants

Laboratory Case Study

The situation

Using lean manufacturing methodologies, PharmOut helped a pharmaceutical company in Australia identify laboratory testing as a bottleneck in their manufacturing process and stock holding wastage. 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’s lean pharmaceutical consultants recommended that the company invest in new instrumentation which provided rapid online results and which complied with the FDA’s, process analytical technology (PAT) guidelines. This substantially reduced the load on the QC laboratory and remove the bottleneck. In addition, PharmOut worked on a Value Stream Mapping exercise with the client and by focusing on the laboratory initially the concepts and principles were rolled out to the rest of the company.

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 and capital invested in the operating cycle.