Annex 1 in Practice: How Component Design and Manufacturing Support Your Contamination Control Strategy

Annex 1 raised the bar on contamination control. Learn how component design, clean room manufacturing, and documentation can strengthen your CCS—and what to expect from packaging partners under the new standard.

Register Free: https://www.pharmtech.com/pt_w/annex-1

Event Overview:

This webinar examines how primary packaging and drug delivery component selection, manufacturing, and supplier documentation directly support a sterile manufacturer’s contamination control strategy (CCS) under EU GMP Annex 1. Datwyler subject matter experts will walk through practical examples of component-level controls—including elastomer formulation choices, clean room–classified production, particulate and extractables testing, and qualification documentation—that quality and regulatory teams can incorporate into their own CCS and audit readiness.

Two years post implementation, many manufacturers are moving from initial compliance to ongoing audit defense and supplier requalification. Understanding what “Annex 1-ready” actually looks like at the component level—not just on paper—helps quality and procurement teams ask sharper questions of suppliers and close gaps before inspectors find them.

Attendees will leave with a practical framework for evaluating packaging/component suppliers against Annex 1 expectations, example documentation structures to request during qualification, and a clearer picture of where component-level risk typically hides in sterile fill-finish operations.

Key Learning Objectives:

• Map Annex 1 CCS requirements to component-level controls
• Identify documentation to request during supplier qualification
• Recognize common particulate and E&L risk gaps
• Apply audit-readiness criteria to packaging component sourcing

Who Should Attend:

• Quality assurance and quality control managers in sterile/parenteral manufacturing
• Regulatory affair professionals overseeing CCS and submission documentation
• Packaging engineers and component sourcing/procurement leads
• Manufacturing/operations leaders responsible to fill-finish lines
• Supplier quality auditors

Speaker:

Alison Phillips
Technical and Scientific Expert
Datwyler

Alison Phillips completed her bachelor’s degree in chemistry at the University of Pittsburgh and her doctorate in chemistry at the University of Maryland. During her graduate studies, Phillips spent time as a research assistant and teaching assistant and was the recipient of a fellowship sponsoring her research at the National Institute of Standards and Technology in Gaithersburg, Maryland.

After graduation, Phillips spent 10 years in technical services in the specialty chemical industry, where she managed a team of chemists who focused on supporting customers and their process and product development. In 2024, Phillips joined Datwyler Sealing Solutions as a technical and scientific expert, where she works alongside Datwyler’s sales team to educate customers and industry experts on key considerations when choosing parenteral packaging components.

Register Free: https://www.pharmtech.com/pt_w/annex-1