The firm concluded that a new solution was required to resolve an on-going QC sample back log issue and an overall lack of operational efficiency within the quality function.

The Process:

Smart Pharmaceutical Consulting conducted a thorough in-depth analysis of: the workflow (including chain of custody), personnel capabilities, training, equipment suitability, facility organization, IT infrastructure and regulatory compliance.

The analysis looked for best practices and assessed areas for new opportunities to drive operational efficiencies.

With the analysis complete a three stage “Forward Strategy” was developed which would take advantage of technological solution opportunities such as PAT, LIMS integration and streamlined IT infrastructure.


  • Using a PAT solution removed a significant QC testing function by deploying the analysis in the manufacturing plant. Using an in-line electrode to achieve the same endpoint, time was saved and this created potential for a reduction in the process cycle time. This was a new best practice for the company.
  • A refocusing of the QC release workflow through a sister laboratory enabled significant efficiencies to be driven into the system.
  • Controlling staff training to focus key expertise raised the team’s capability and reduced issues connected with Right First Time analysis and laboratory investigations.
  • Value was driven into the system by redesignating the planning and scheduling mechanism.
  • A move to implement state of the industry data capture and manipulation technology such as LIMS, on-line sample log-in capability and integrated data calculating capability reduced sample lead times and improved efficiency for the analysis process.
  • A commitment to habit changing methodology through neural reconditioning to support training and analyst certification created a more positive work experience for the staff and helped to drive pride back into their work product. This resulted in a reduction in the number of errors.
  • Grassroots lead initiatives supported by management changed habits which resulted in a significant improvement in laboratory output and efficiency.

Through the application of a holistic approach, many of the issues in the QC laboratory/Quality group were determined to be influenced by issues outside of the Quality function. Moreover, through the application of cross functional analysis, solutions based upon wider technology functions were found to produce the most significant results.