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Philip Hoersch, PhD, is director, Quality Assurance-Validation/RiskManagement/Trending, Vetter Pharma-Fertigung GmbH & Co. KG.
The author reviews operative options for the implementation of a quality oversight and how companies can benefit from this function from a regulatory perspective.
The concept of quality oversight is increasingly used in the context of GMP-compliant production operations. It represents the quality understanding of a pharmaceutical manufacturer as well as the involvement and responsibility of management. In this context, it includes the quality systems implemented to enable compliance with internal and regulatory specifications and regulations. The author reviews operative options for the implementation of a quality oversight and how companies can benefit from this function from a regulatory perspective.
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When referring to this article, please cite it as P. Hoersch, "Quality Oversight During Sterile Filling Operations," BioPharm International Outsourcing Resources eBook (March 2018).