A large mid-western pharmaceutical company desired to develop and implement a GMP service provider quality assessment/management program. The company had developed a corporate level procedure but had not develop local procedures or practices to allow effective implementation and use. additionally, the concept of supplier quality assessment was new to the company.
Performance Validation provided a dedicated resource with significant quality expertise to assist the company’s team in the development, training and implementation of this new quality process. Specifically Performance Validation provided the following:
- Assistance in developing the site-specific supplier quality assessment program through review of the corporate policy, ISO9001:2000 requirements, various standards and benchmarks of supplier quality as sourced from the pharmaceutical, chemical and manufacturing industries.
- Standard assessment tools were developed which enabled consistent impartial and unbiased assessment of service providers.
- Training with respect so supplier quality concepts and use of the supplier assessment tools.
- Anticipated assessment of over 100 service providers using the standardized assessment tools
- Management of the assessment process which included:
- Issue of assessment packages
- Tracking of complete/incomplete assessments
- Receipt of completed assessments
- Compilation and evaluation of data
- Summary and supplier disposition recommendation
The supplier assessment and management system was successfully implemented and ongoing management of the process was turned over the to client company.
The completed project accomplished the following for the manufacturing facility:
- Provided a compliant solution to a mandated corporate requirement.
- Provided a scalable supplier quality assessment program although this program was developed for one site, this work has been leveraged across multiple sites which provides
- Consistency in supplier assessment practices across the organization, and
- An overall reduction in the initial development/implementation cost.
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Vice President, Indiana Division Director