After performing internal audits, a major pharmaceutical company discovered inconsistencies in their product storage compliance. These inconsistencies meant they were unable to ensure that temperature sensitive products would be stored and distributed within the correct temperature ranges indicated by industry-standard data.
To address this, a mandate was issued by Quality leadership to open a CAPA with the following elements:
Risk assessment to identify and prioritize relevant products
Definition of storage and distribution temperatures requirements
Temperature map of all storage facilities
Temperature map of all shipping lanes
Establishment of ambient temperature profiles
Design, development, and qualification of all active and passive shipping solutions
Endeavor was able to provide a Cold Chain Packaging Specialist, who had the skills needed to effectively execute the CAPA. Additionally, this Specialist provided product lifecycle management support, particularly in regard to the temperature control of the supply chain.
With this expertise, Endeavor was able to put a global program into place that addressed the international business and regulatory needs, despite the complexity inherent in the situation.
Included in the program was the development of multiple product recipes, all of which could be fully managed by a native SAP solution. The solution was fully integrated with SAP planning, materials management, quality, and plant maintenance modules.
Endeavor's solution is fully functional in multiple work centers within one manufacturing plant. Plans are currently in place to provide a full “end to end” Electronic Batch Record, which will include all work centers and multiple production plants.
The system has met or exceeded all business metrics for enforced compliance, operational efficiency, and quality release. Our solution is based on standard SAP technology with minimal customization and is now fully supported by the client's internal SAP staff via one FTE.
Due to the use of standard SAP technology, the solution is fully integrated with all SAP functions and naturally fits as new SAP functions are provided in other business areas.