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From carrier oil qualification to serial production of an oil-based vitamin D3 supplement in several dosage strengths for Central Asian markets.
The project involved developing and manufacturing an oil-based vitamin D3 supplement in several dosage strengths for Central Asian markets. Although the formulation was technologically straightforward, the target market's regulatory requirements demanded particular attention. The carrier oil accounted for approximately 98% of the formulation. Its quality, batch-to-batch consistency and compliance with strict contaminant limits were therefore central to the project. Raw material selection had to be aligned with the documentation and requirements of future serial production.
We selected and qualified the carrier oil, considering analytical results, quality consistency and stability. The assessment reflected both the target market's requirements and the oil's role in the finished formulation.
We optimised the formulations for scale-up and consistent manufacturing. Formulation work was linked to preparing the individual dosage strengths for production.
We developed a documentation package covering stability, raw material quality and regulatory justifications, connecting product requirements with the documents needed for implementation.
We coordinated the project from concept to serial production, bringing together formulation, raw material sourcing, documentation and manufacturing implementation.
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