Process Improvement for Drug/Biologics Manufacturer

QSN assisted a drug/biologics manufacturer with the successful completion of a process improvement initiative which significantly reduced their qualification process time, lowered costs, and decreased labor requirements – while establishing a documented process.

Company profile

  • Established in the early 60’s to discover and develop innovative medicines that cure human disease.
  • Therapeutic areas include: cardiovascular and metabolism, immunology, infectious diseases and vaccines, neuroscience, and oncology.
  • Many new products emerging from the pipeline, and did not have the documented processes in place (21 CFR Part 211) to easily handle the influx of work.

Business situation

The drug/biologics manufacturer’s approach to developing controlled temperature shipping systems, used to transport drug products throughout the distribution channels, had been to qualify each shipping solution for each individual new drug product. The current qualification process included complete thermal and distribution testing, which took approximately twelve months to complete. Expenses were incurred to contract out testing, purchase test materials, and pay for labor. The company wanted to reduce this time, lower costs, and decrease labor requirements, in addition to establishing a documented process.

Technical situation

The drug/biologics manufacturer had the package engineering expertise to eliminate thermal and distribution testing by developing a leveraging process to justify the use of previously qualified shipping solutions for new drug products. The company required external support to assist in the development of the rationale, process, and documented method for accomplishing this effort.


QSN was appointed to develop the business case, and a team was assembled to kick off the project. QSN facilitated team meetings and all working sessions. A time study was conducted of the current process which supported the business case to develop a leveraging process that would serve as a means of establishing thermal equivalence between the controlled temperature shipping system for the existing, qualified drug products and the new drug products. QSN completed a project charter, communication plan, and a multi-generational plan to manage the project activities. Various Six Sigma tools were used to understand the as-is versus the future state process, including a Pareto chart, flowcharts, SIPOC, CTQ tree, voice of customer, process maps, RACI matrix, KPIV/KPOV, and FMEA. QSN coordinated all efforts related to the new process, including the review of all work instructions and templates.


QSN led the team to the implementation of the new process. The benefits of the project included a reduction in cycle time of over 50%, a cost avoidance of over $450K in thermal and material costs, and a labor avoidance of 2.5 full time exempt employees. Not only was productivity increased, but the documented process addressed compliance issues detected through the internal audit program. The next internal audit conducted by the client was conducted with minimal findings.