Hardware Podcasts

151 - Primary Packaging/Container Closure Change Guidance, Post-Approval Changes, Sponsor/Supplier Relationships, Purchasing Controls and Tubular vs. Molded Glass with Fran Degrazio

Let's Combinate · 28 Aug 2024 · 33m

What this episode covers

Fran Degrazio, President of Strategic Parenteral Solutions and former Chief Scientific Officer at West Pharmaceutical Services, explains the FDA's new guidance on primary packaging changes for glass vials and stoppers. She details the complexities of sponsor-supplier relationships, emphasizing that change management is the most critical aspect of purchasing controls and supplier qualification. The discussion highlights the technical and regulatory differences between tubular and molded glass, noting that dimensional tolerances and system-level interactions drive stricter reporting requirements like Prior Approval Supplements (PAS).

Most relevant to

established companies

Topics

Mentioned

Companies
Strategic Parenteral Solutions, West Pharmaceutical Services
Also
Drug Delivery Leader, FDA

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