In this article reprinted from Pharmaceutical Manufacturing, CDC Software explores the management of outsourced manufacturing in the life sciences. But even when outsourcing the manufacturing of a good, the company itself is still responsible for ensuring compliance.
The Food & Drug Administration (FDA) dictates that the marketer submitting a therapy for regulatory approval is ultimately responsible for the end-to-end safety and compliance of the product. This includes all sourcing, materials management, manufacturing, packaging and shipping, even when these functions have been outsourced.
Through the use of standard, off-the-shelf technology, companies are proactively ensuring adherence to Good Manufacturing Practices, speeding the time to market and reducing production costs without directly managing the manufacturing or materials management process.
Among the benefits:
- Lower headcount
- Improved forecasts
- Supplier performance can be measured and optimized
- Improved production performance data provides tools for better decision-making.
Read the full paper.