Webinars, Pharmaceutical

Advanced Parenteral Closure Solutions: The Perfect Fit Towards Compliance with EMA GMP Annex 1 Revision

Aptar Pharma’s presence at Pharmapack 2024 was notably marked by Estelle Verger, Business Development Manager who took the stage as a featured speaker. During her presentation, she outlined the significant updates brought by the newly revised Annex 1, with a particular focus on the enhanced importance of risk management, contamination control, and quality assurance throughout the drug manufacturing process. These changes highlight the necessity for pharmaceutical firms to establish both a pharmaceutical quality system and a strategy for controlling contamination. Primary packaging being an integral part of the final combination product, its performances must be in line with these regulatory changes to support compliance of the pharmaceutical partner and protect patient health.

Watch Advanced Parenteral Closure Solutions Video
Speaker(s): Estelle Verger
3 Apr 2024

Ensuring that the materials and designs chosen for primary packaging are appropriate is crucial to minimize the risk of contamination, drug product interactions, and exposure to environmental factors, in accordance with the revised requirements of Annex 1. This is relevant not only for the primary packaging containers but also for components such as vial stoppers, syringe plungers, or Rigid Needle Shields. Estelle Verger also discussed  how Advanced Parenteral Closure Solutions assist in complying with the Annex 1 revision.

Aptar Pharma’s PremiumFill® solutions offer pharmaceutical companies improved quality for vial stoppers and syringe plungers, which can support patient safety and enhance operational efficiency. Manufactured in an ISO7 cleanrooms and utilizing robotic technology, Aptar Pharma ensures enhanced specifications for particles, fibers and biological contaminants, which are identified as key concerns in the Annex 1 revision.

Regarding the sterility of primary packaging, the Annex 1 revision stipulates the requirement for proof of sterility and packaging integrity at the point of use. Aptar Pharma’s Ready-to-Use gamma sterilized components are uniquely packaged to allow for easy packaging integrity verification. Accompanied by gamma irradiation indicators and certificates, the sterility of components is guaranteed at the time of use, which supports pharmaceutical companies in demonstrating adherence to the Annex 1 revision on sterility assurance.

The Rapid Transfer Portbags, another component of the Advanced Parenteral Closure solutions, enables direct connection to isolators, significantly reducing contamination risks during the sterile component transfer to filling lines. Following the Annex 1 revision, isolators are the only method of aseptic transfer that is recommended.

In summary, this presentation emphasized the pivotal role of primary packaging in pharmaceutical production and its central position on meeting regulatory standards as per the updated Annex 1. By focusing on quality, risk management, and selecting the right primary packaging partner, pharmaceutical companies can improve the safety, effectiveness, and outcomes for patients, while ensuring they abide to the latest regulatory requirements.

This presentation could serve as a valuable guide for Heads of packaging, R&D professionals, and supply partners engaged in the sphere of injectable drug development and regulatory matters. It offered valuable information and insights, empowering attendees to navigate the shifting sands of the regulatory landscape. By focusing on primary packaging considerations, the talk provided clear, actionable guidance to ensure compliance with the recent Annex revision, marking it as a crucial resource for industry stakeholders aiming to stay ahead in the rapidly evolving world of healthcare.

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