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Cutting costs on a pharmaceutical transformation project
GMP transformation: from device to veterinary medicine
For a product release to a south pacific market, Contura International needed to change the status of a medical device to veterinary medicine. Reduced costs, increased speed to market and a project plan based on GAP analysis and former reports were some of the major requirements. Based on Eltronic’s experience with QMS, LEAN and project management, Contura turned to Eltronic for the GMP transformation of the project.
A lean and pragmatic transition
Only a few batches of the pharmaceutical product are produced a year. Therefore, Eltronic needed to perform a lean and pragmatic transition from device QMS to GMP. Eltronic identified three central areas of investigation with potential for cost saving: raw material definition, the environmental monitoring strategy and GAP analysis.
Exceptions in the regulation
A thorough investigation led Eltronic to find exceptions of central importance in the regulations. The raw material for compounding the final product could be defined as starting material and the requirement for environmental monitoring could be lessened as the customer was producing veterinary medicines with terminal sterilization. Furthermore, Eltronic performed a GAP analysis of the existing QMS ensuring that only the required GMP procedures were added to the existing system.
Eltronic’s immense insights into the pharmaceutical rules and procedures enabled unexpected savings as the future control and analysis of receiving raw materials for the veterinary medicine was mitigated and the requirement for raw material audit was made redundant. The GAP analysis allowed transformation of the QMS into a fully GMP compliant system.
GMP transformation lead time
The transformation of Contura’s documentation and mindset - guided by Eltronic’s expertise - resulted in the project being completed in record time. As a final step, the inspection by the Danish Medicine Agency was successful.
Ongoing drug approval
Eltronic has been appointed qualified person (QP) for the ongoing drug release.
About Contura International
One of Contura's activities is to produce drugs for other pharmaceutical companies as a contract manufacturing organization (CMO). A company using Contura as CMO for their own brand, a polymer filler for veterinary purposes, was forced to register the medical device as veterinary medicine on specific markets. Contura was contractually obliged to see the transformations through and sponsor the project.
The Steps of the Project
“Eltronic was able to act quickly, competently and professionally. The transformation was in safe hands and during the process we never doubted the final result! And we were right!”
Maibrit Søe (QA Director) and Lars Trolle (CEO) at Contura International
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Director, Pharma Engineering