To take advantage of the opportunity, the enterprise strategic sourcing manager contacted the manufacturer and negotiated a direct purchase agreement delivering the client significant savings.
In the process of implementing those savings, the RS team worked closely with both the client and the manufacturer in ensuring the product was manufacturer-equal and that all appropriate documentation, including certification of compliance, were provided, and verified as required by the site’s GMP (Good Manufacturing Practice) designation, before the product was installed on the production floor.
When completed, the same concept was shared with additional sites within the client’s network, thereby extending the program benefits across the enterprise while remaining GMP compliant.
In some cases, when similar modifications are made, a change management process is triggered. Those usually center on a change to the form, fit and function of the part. In this case, however, it was the same part sourced directly from the manufacturer. The process maintained compliance with the site’s GMP requirements (including the proper documentation for any FDA audits).
The industry’s regulation and government oversight mandates additional steps to maintain the integrity of the supply chain. Certification of conformance is one measure, as is USP VI Testing, which evaluates several types of plastics materials used in the production or packaging of pharmaceutical products. The goal is to protect the purity of the final product without introducing cross contamination to the production environment.