
- BioPharm International-03-15-2018
- Volume 2018 eBook
- Issue 1
Quality Oversight During Sterile Filling Operations
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.
View other articles in
Article Details
BioPharm International
eBook: Outsourcing Resources 2018
Vol. 31
March 2018
Pages: 11–15
Citation
When referring to this article, please cite it as P. Hoersch, "Quality Oversight During Sterile Filling Operations," BioPharm International Outsourcing Resources eBook (March 2018).
Articles in this issue
almost 8 years ago
Good Quality Agreements Support Compliance with CGMPalmost 8 years ago
Gaining Analytical Insight in the Development of Biologicsalmost 8 years ago
Contract Services Investment Updatealmost 8 years ago
Process Validation in Biologics Developmentalmost 8 years ago
Bigger is Better in Samsung's Approach to Biomanufacturingalmost 8 years ago
Choosing an Analytical Partner in Early Drug Developmentalmost 8 years ago
Outsourcing: Does Focus Pay Off?almost 8 years ago
Avoiding Complete Response LettersNewsletter
Stay at the forefront of biopharmaceutical innovation—subscribe to BioPharm International for expert insights on drug development, manufacturing, compliance, and more.





