CASE STUDY

A North American Pharmaceutical Company engaged with RCM to assist in developing a Quality Remediation Program to address current quality issues. The objectives were to improve processes, integrate new methods and techniques, and build a Quality Culture of continuous improvement. 

Data Analytics

OBJECTIVE

A North American Pharmaceutical Company engaged with RCM to assist in developing a Quality Remediation Program to address current quality issues. The objectives were to improve processes, integrate new methods and techniques, and build a Quality Culture of continuous improvement. 

Specific Goals:

  • Find the ‘root cause’ of poor quality and develop a plan to improve overall quality
  • Implement new Techniques to enable continuous improvement
  • Introduce new methods,  such as Quality by Design, to Quality Assurance (QA) and Quality Control (QC) to aid in building  a Quality culture of continuous improvement.

SOLUTION

  • RCM Advisory Services – Regulatory Advisory consultant assembled a team and recommended a  phased approach to included: remediation planning, root cause identification, remediation with short-term solutions, and continuous improvement training.
  • Remediation activities prioritized when  data  was gathered through findings, comments, and discussions on continuous improvements.
  • Improvement techniques included QA and QC training on new methodology, such as Quality by Design.
  • Actionable items were tracked, corrected, reported, and eliminated.
  • Weekly, Monthly, and Quarterly review with senior management were conducted.
  • Documents were revised to meet FDA requirements.
  • Additional resources were added as needed to complete the phased approach to remediation.

BENEFITS

  • RCM efforts allowed the Client to address the critical remediation activities quickly and completely.
  • Client personnel was educated on FDA regulations, CSA and new methods for continuous improvement. 
  • Through collaboration and teamwork, RCM and Client succeeded in building a Quality culture that embraced continuous improvement.

Key Project Elements

Remediation that mitigated future risk

 Quality documents that aligned with FDA

Mandatory  Employee Training

Quality culture

 that embraces 

continuous improvement