Webinar

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

Connect EU GMP Annex 1 contamination control strategy requirements with practical controls for primary packaging and drug delivery components.
Learn what manufacturing, testing and qualification documentation to request from component suppliers.
Identify component-level microbial, particulate, endotoxin/pyrogen and material-interaction risks before they become inspection findings.

Status Published

Format Webinar

Language English

Access Registration Required

Watch the Webinar

Resource Overview

About This Annex 1 Webinar

A contamination control strategy is only as strong as the controls supporting every material, component and process that enters the sterile manufacturing environment.

This webinar examines how primary packaging and drug delivery component selection, design, manufacturing and supplier documentation can support a sterile manufacturer’s contamination control strategy under EU GMP Annex 1.

Datwyler subject matter experts will walk through practical examples of component-level controls, including elastomer formulation and coating choices, cleanroom-classified production, automated inspection, particulate testing, extractables and leachables assessments, sterilization validation and qualification documentation.

The session is designed to help quality, regulatory, packaging and procurement teams evaluate whether component suppliers can provide the controls and evidence needed to support qualification, ongoing risk management and inspection readiness.

How to map relevant Annex 1 contamination control strategy expectations to primary packaging and drug delivery component controls.
Which manufacturing, testing, validation and change-control documents to request during supplier qualification.
Where microbial, particulate and endotoxin/pyrogen contamination risks can arise across component manufacturing, packaging and transfer.
How elastomer formulations, coatings and extractables and leachables assessments contribute to broader drug–component compatibility risk management.
How to apply practical audit-readiness criteria when evaluating or requalifying a packaging component supplier.

Watch the Webinar

Watch the Webinar On-Demand

Start the on-demand session instantly after quick registration.

Watch the Webinar

Quick access in under 30 seconds.

Expert Spotlight

Meet the Expert

Alison Phillips, PhD

Technical and Scientific Expert · Datwyler

Alison completed her Bachelor’s of Science, Chemistry, at the University of Pittsburgh and PhD in Chemistry at the University of Maryland. During her graduate studies, Alison spent time as a research assistant, teaching assistant, and was the recipient of a fellowship sponsoring her research at the National Institutes of Standards and Technology (NIST) in Gaithersburg Maryland.

After graduation, Alison 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, Alison 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 the important considerations involved in choosing parenteral packaging components.

Email LinkedIn