Biological Vial: More than Just a Pretty Package
What are manufacturers' main concerns for packaging? They want components that operate well with their filling lines and their full range of processing. If every time they run 1,000 stoppers down the line, things get stuck because they are not dimensionally correct, they have big problems. Their regulatory application and product approval can be delayed. So from a regulatory standpoint, working with a reliable package supplier with sound drug master files and applicable processes, is critical in getting drug and biologics to market. Ten years ago, everybody just said, "Hey. It's only packaging. . . I'll take whatever is in our inventory, and use that," without always understanding the magnitude of risk.
Fran DeGrazio has worked in pharmaceutical packaging for 21 years and has extensive expertise in the area of injectable drug products. DeGrazio is currently vice-president of quality assurance for West Pharmaceutical Services (which produces packaging components and does some laboratory analysis) and has responsibility for quality control for nine manufacturing facilities and the corporate analytical laboratories. In 2004, she assumed direction for the regulatory group also. She is a member of the Parenteral Drug Association (PDA), American Chemical Society (ACS), Women in Packaging, and the American Association of Pharmaceutical Scientists (AAPS).
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