How RTU Solutions Can Meet GMP Annex 1 Requirements

Pre-sterilised ready to use containers as a compliant aseptic solution, reducing contamination risk and simplifying EU GMP Annex 1 compliance.

Date

November 14th, 2024

Time

4pm (CET) / 10am (ET)

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OVERVIEW

The current EU GMP Annex 1 emphasizes the importance of handling critical manufacturing steps and managing risks associated with contamination. It is crucial for pharmaceutical companies to align their quality management system and establish appropriate Contamination Control Strategy (CCS) and Quality Risk Management (QRM).

By choosing Ready-To-Use (RTU) containers, pharma companies can remove critical operating units and significantly automate their manufacturing process and reduce human intervention, minimizing potential risks of contamination connected to the washing and depyrogenation phases, making operations leaner, and allowing pharmaceutical companies to focus on key activities with the most added value.

In this webinar we discover how RTU containers can be a smart solution to aseptic manufacturing challenges, meeting regulatory requirements and reducing the risk in client’s operations throughout the process with EZ-fill® platform, a fully integrated pre-washed and pre-sterilized containment solution for aseptic manufacturing.

We will deep dive into the benefits for Pharma Companies of adopting RTU solutions:

Reduced contamination sources
Reduced Total Cost of Ownership – simplified CCS implementation and reduced costs of Isolation Technology
Preserved container quality for patients’ safety

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Addressed Challenges

01Achieving compliance with revised GMP Annex 1 sterility requirements while managing the economic and operational impact of necessary process changes.

02Scaling flexible sterile manufacturing capacity globally while maintaining contamination control standards and regulatory compliance at every site.

03Reducing process complexity and implementing effective contamination mitigation measures to protect the quality and safety of final injectable products.

WHAT YOU WILL LEARN

01Understand how RTU pre-sterilised platforms support compliance with EU GMP Annex 1 by eliminating critical washing and depyrogenation process steps.

02Learn how RTU solutions help pharmaceutical companies de-risk sterile manufacturing operations and reduce contamination exposure throughout the process.

03Discover how outsourcing to experienced partners using RTU platforms can reduce total cost of ownership and allow focus on core manufacturing activities.

SPEAKERS

Mirko Gabriele

Pharmaceutical and Innovation Consultant

Mirko is a passionate advocate of pharma and innovation, and he is currently bringing this passion in his role of health-tech advisor. He has over 20 years of experience in the Pharma industry predominantly in Technology Transfer and Operations. As a result of his ability to successfully execute all stages of the technology transfer process, he was promoted from site roles to global roles, with the opportunity to work on Technology Transfer Policy harmonization and best practices improvement and sharing. He successfully covered several dosage forms projects, from Oral to Combination products with a strong expertise in Sterile.

Andrea Salmaso

Regulatory and Scientific Affairs Manager, Stevanato Group

Andrea holds a Pharmacy degree from the Faculty of Pharmacy, Department of Pharmaceutical Sciences, University of Padua (Italy). He is a member of ISO / TC76 / WG2-Rigid container systems and related accessories for Parenterals and Injectables. After a long experience in Quality Assurance in the pharmaceutical industry and medical devices, he joined Stevanato Group, where he held the position of QA Manager for Pre-fillable Syringes production. He is now the Regulatory and Scientific Affairs Manager.

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