The Next Generation Approach to Elastomeric Closures for Sterile Products

The current pharmaceutical market has faced a variety of challenges, including increasing expectations for quality from end-users and regulatory agencies driven by concern for patient safety. While pharmaceutical companies are working to assure that new quality and compliance paradigms are met, a balance must be achieved between the reality of managing costs to provide a [...]

Quality Solutions Mitigate Total Cost of Ownership

In an earlier post, I discussed how the changing market, regulatory expectations and quality issues have an impact on a pharmaceutical manufacturer’s total cost of ownership. There are a variety of solutions that are currently available to aid with these issues, and thus lower the total cost of ownership. For example, modern polymeric materials can [...]

The Price of Quality

The FDA initiated a framework to modernize the way pharmaceutical and biopharmaceutical products are developed, manufactured and used through the use of data and science-based decision making.  This was visualized when they published a concept paper on current Good Manufacturing Practices for the 21st century in mid-2002. This was followed by the International Conference on [...]