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

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2024-08-28
- Length: 33m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2024-08-28-151-primary-packaging-container-closure-change-guidance-post-approval-changes-sp
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/151---Primary-PackagingContainer-Closure-Change-Guidance--Post-Approval-Changes--SponsorSupplier-Relationships--Purchasing-Controls-and-Tubular-vs--Molded-Glass-with-Fran-Degrazio-e2nmqpg

## Summary

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).

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2024-08-28-151-primary-packaging-container-closure-change-guidance-post-approval-changes-sp#t=0) Introduction: Fran Degrazio and Strategic Parenteral Solutions
- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2024-08-28-151-primary-packaging-container-closure-change-guidance-post-approval-changes-sp#t=0) FDA Guidance Background: COVID-Driven Flexibility for Vials and Stoppers
- [4:59](https://hardwarepodcasts.com/podcast/lets-combinate/2024-08-28-151-primary-packaging-container-closure-change-guidance-post-approval-changes-sp#t=299) Supplier Management Challenges: Change Agreements and Notification
- [7:20](https://hardwarepodcasts.com/podcast/lets-combinate/2024-08-28-151-primary-packaging-container-closure-change-guidance-post-approval-changes-sp#t=440) Navigating Change Management: CBE-30 vs. PAS Reporting Categories
- [11:37](https://hardwarepodcasts.com/podcast/lets-combinate/2024-08-28-151-primary-packaging-container-closure-change-guidance-post-approval-changes-sp#t=697) Regulatory Compliance: Managing Raw Material Suppliers and Risk
- [25:19](https://hardwarepodcasts.com/podcast/lets-combinate/2024-08-28-151-primary-packaging-container-closure-change-guidance-post-approval-changes-sp#t=1519) Dimensional Tolerances: Tubular vs. Molded Glass Systems

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Manufacturing partners & offshoring](https://hardwarepodcasts.com/topic/manufacturing-partners)
- [Materials & manufacturing processes](https://hardwarepodcasts.com/topic/materials-and-processes)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)

## Most relevant to

established companies

## Mentioned

- Strategic Parenteral Solutions (company)
- West Pharmaceutical Services (company)
- Drug Delivery Leader (other)
- FDA (other)

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- [201 - Jonathan Cage is Crazy About Packaging](https://hardwarepodcasts.com/podcast/people-of-packaging/2023-07-05-201-jonathan-cage-is-crazy-about-packaging) (People of Packaging)
- [S6E51 Eric Richins | What It's Like Being A Packaging Engineer](https://hardwarepodcasts.com/podcast/being-an-engineer/2025-12-19-s6e51-eric-richins-what-its-like-being-a-packaging-engineer) (Being an Engineer)
- [#467: Combination Product Compliance: PMOA, 21 CFR Part 4 & QMS Alignment](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-08-03-467-combination-product-compliance-pmoa-21-cfr-part-4-qms-alignment) (Global Medical Device Podcast)
- [#474: Behind the QMSR Audits: The Top 5 FDA Citations & Risk Management Pitfalls](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-09-21-474-behind-the-qmsr-audits-the-top-5-fda-citations-risk-management-pitfalls) (Global Medical Device Podcast)

## Citing this page

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