Publications, Pharmaceutical

Injectable Primary Packaging support compliance with Annex 1 Revision

The pharmaceutical industry is consistently focused on ensuring the safety and efficacy of injectable drugs, with particular attention to the challenges of particulate contamination and sterility. These concerns have led to numerous recalls by the FDA in recent years and have highlighted the critical need for strict oversight and control in manufacturing processes. The development of highly sensitive biologics and biosimilars, which require maximum protection at all stages from manufacturing to delivery, adds complexity to these challenges. Additionally, evolving and increasingly stringent regulatory standards place the pharma industry under further pressure to guarantee the cleanliness and safety of their products.

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Author(s): Edouard Pagnoud Estelle Verger Benjamin Brocco
13 Oct 2023

Recently, the European Medicines Agency (EMA) revised Annex 1 of the Good Manufacturing Practices (GMP), placing a strong emphasis on contamination control across all aspects of production and the supply chain. Manufacturers are now required to implement a comprehensive Contamination Control Strategy (CCS) and must provide assurance of sterility for their products, which may necessitate adjustments to processes and supply chains to comply with these enhanced standards.

Aptar Pharma, a leader in the production of vial stoppers and Pre-Filled Syringe plungers, has introduced a range of advanced parenteral packaging solutions designed to meet the specific needs of Pharma companies for limiting risks of contamination on their filling lines. Aptar PremiumFill® solutions offer improved specification on key contamination criteria that guarantees higher quality levels for meeting annex 1 requirements on contamination controls while also enhancing operational efficiency with the potential of reducing costs associated to rejects.

The Ready-to-Use (RTU) gamma sterilization process ensures sterility at the time of use, providing an additional layer of safety and reliability. RTU products also help our customer streamline their operation by avoiding the load of sterilization validation, which is performed by Aptar Pharma.

Finally, the Annex 1 revision strongly recommends the use of isolators or Restricted Access Barrier Systems (RABS). Such operations require the use of Rapid Transfer Port (RTP) bags, of which Aptar Pharma offers a wide variety of design, to meet the requirements of your operations.

In a complex and strictly regulated environment, Aptar Pharma provides innovative and reliable solutions that adhere to and anticipate the evolving needs of the pharmaceutical industry. Through a commitment to quality, safety, and operational efficiency, Aptar continues to influence the future of pharmaceutical manufacturing, ensuring that the industry is prepared to meet both current challenges and future uncertainties.

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