Best Practices for Meeting and Exceeding Regulatory Standards in Primary Packaging: USP <381> and <382>

Webinar

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

In this webinar, experts will demonstrate how primary packaging component design, manufacturing controls, and supplier documentation directly support your contamination control strategy under EU GMP Annex 1 — with practical tools for mapping CCS requirements to component-level controls, sharpening supplier qualification, and closing audit readiness gaps before inspectors find them.

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White Paper 2026 Report

Double Sterilization in Pharmaceuticals: The Impact of Annex 1 on Component Strategy

Since the 2022 revision of EU GMP Annex 1, double sterilization has emerged as a new compliance standard for injectable packaging — but combining RTU components with terminal sterilization creates real complexity in method selection, component performance, and validation strategy. This report examines how Annex 1 is reshaping sterilization decisions for elastomeric components, from steam vs gamma trade-offs and cumulative irradiation effects on plunger functionality, to the validation data requirements manufacturers must plan for from day one.

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Technical Article

Annex 1 Sterilization: Why Pharma Packaging Strategy Is Changing

The 2022 revision of EU GMP Annex 1 has fundamentally raised the bar for sterile manufacturing — and for primary packaging components, it means sterilization strategy can no longer be an afterthought. This article explores how the shift toward double sterilization is changing how manufacturers evaluate RTU elastomers, select between steam and gamma, and build contamination control strategies that hold up to regulatory scrutiny.

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