
|Articles|May 15, 2017
- BioPharm International-05-15-2017
- Volume 2017 eBook
- Issue 1
Quality Metrics and CMO Agreement
FDA’s focus on the quality culture and its request for quality metrics may ensure a successful company-CMO relationship.
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As Naheed Sayeed, Ajay Pazhayattil and Jena Spes of Apotex write, FDA’s guidances on quality agreements and quality metrics came at just the right time to address ongoing issues. Both guidances should benefit the industry, but, above all, the consumer, by establishing a framework for developing a culture of quality.
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Articles in this issue
about 9 years ago
Customer Relationship Management in Contract Manufacturingabout 9 years ago
Getting Biopharmaceutical Tech Transfer Right the First Timeabout 9 years ago
CMOs Tackle New Challengesabout 9 years ago
Gearing Up for Biosimilarsabout 9 years ago
Insourcing vs Outsourcing: Choosing the Right Strategyabout 9 years ago
Operations and Quality Oversight of CMOsAdvertisement
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