Bethesda, Md., May 19, 2016 – The Parenteral Drug Association (PDA) today launched a pilot for its Quality Culture Assessment Tool with an assessor training session. Members of PDA’s Quality Culture Maturity Task Force met with six auditors from two companies to introduce the assessment tool and learn how to apply it to simulated manufacturing case studies. The purpose of the pilot is to work with assessors from up to 20 different pharmaceutical companies to refine the assessment tool. The assessment tool is intended to help companies advance their overall quality culture maturity by identifying attributes that are strengths as well as others that are ready for improvement.
"PDA is developing this tool for assessing quality culture maturity within a manufacturing site so that companies can perform internal assessments of their own operations as well as audits of their suppliers and contract manufacturers," said PDA President Richard Johnson. "The pilot is an important step in developing the Quality Culture Assessment Tool to ensure that it is optimized for wider industry use."
During the pilot, the task force developing the tool will be assessing:
- Reproducibility—is the tool objective and verifiable?
- Differentiability—can the tool differentiate sites?
- Training effectiveness
Using the tool, assessors will look at various aspects of a manufacturing site to determine how mature the quality culture is. These attributes of quality culture include: leadership commitment, communication & collaboration, employee ownership, continuous improvement, and technical excellence.
Complementing the tool is a survey that companies will use to gather broad input on quality culture behaviors. PDA will conduct an analysis of the maturity attribute data collected by the assessors and behavior data from the surveys at each site to look for correlations similar to what was found in the PDA Quality Culture Maturity Survey of 2015 (an analysis of which was published in the PDA Journal of Pharmaceutical Science and Technology).Each participating site will receive a copy of the analysis of their individual results.
PDA’s task force already submitted comments on the U.S. FDA’s Draft Guidance for Industry: Request for Quality Metrics, published Points to Consider: Pharmaceutical Quality Metrics, and conducted an industrywide survey on quality culture.