EU GMP Annex 1: New Standards for Injectable Drug Manufacturing

Revised EMA GMP Annex 1 guidelines, impact on contamination control strategy and the role of primary packaging suppliers in sterility assurance.
Date
April 8th 2025
Time
4pm (CET) / 10am (ET)
Presented by:
OVERVIEW

Contamination, both particulate and microbial, remains a leading cause of FDA recalls and poses serious risks to patient safety. To address these challenges, the European Medicines Agency (EMA) has updated Annex 1 of the Good Manufacturing Practices (GMP) guidelines, mandating stricter controls for pharmaceutical manufacturers and their suppliers.

Our experts will break down the revised EMA GMP Annex 1 guidelines, examining their impact on pharmaceutical operations and highlighting the critical role of sterile primary packaging suppliers in achieving compliance.

 

This webinar will provide a clear understanding of the EMA Annex 1 revisions and their impact on pharmaceutical operations. Discover practical strategies for contamination control, including sterility assurance for primary packaging components, and gain insights into how Aptar Pharma’s innovative solutions can support compliance with the updated guidelines.

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Addressed Challenges
01  Developing and implementing a robust Contamination Control Strategy that meets the updated requirements of revised EU GMP Annex 1 guidance. 
02Ensuring best practices for aseptic transfer are embedded across manufacturing operations in line with the elevated sterility assurance expectations. 
03Achieving and maintaining the sterility of primary packaging components throughout the supply chain to comply with revised regulatory standards. 
WHAT YOU WILL LEARN
01Gain insight into the EMA Annex 1 revision, including its regulatory context, scope of application, and implications for pharmaceutical manufacturers. 
02Explore the role of primary packaging suppliers within Annex 1 compliance and how supplier qualification supports contamination control strategies. 
03Learn how Aptar Pharma's injectable solutions support drug manufacturers in achieving compliance with updated GMP Annex 1 requirements. 
SPEAKERS
EU GMP Annex 1 Webinar
Estelle Verger
Senior Manager, Business Development, Aptar Pharma
Estelle Verger is the Business Development Senior Manager for PremiumCoat® coated solutions for Aptar Pharma’s Injectables division, and is responsible for the growth of the PremiumCoat® platform in the global injectable market. A graduate from ESSEC Business School and Fachhochschule Dortmund, with a Masters degree in International Business Management, she joined Aptar Pharma in 2011 as a Sales Manager, Injectables. Estelle then moved to Aptar Pharma’s Consumer Healthcare division as a Product Manager, where she was responsible for Airless Dispensing Solutions for pharmaceutical applications for a number of years, before returning to the Aptar Pharma Injectables division in 2020.
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Wendy Durand
Senior Manager, Regulatory Affairs
Wendy Durand is a Senior Manager Regulatory Affairs at Aptar Pharma’s Injectables division. In her role, Wendy focuses on ensuring compliance with regulatory requirements, product quality, and safety. She has experience from previous roles in various pharmaceutical companies. She is a pharmacist with a Master's degree in Analytical Chemistry from Bordeaux University. She joined Aptar Pharma in 2020.
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