Publications, Pharmaceutical

Helping Pharma Manufacturers Meet New Annex 1 Requirements

In the pharmaceutical industry, the safety and efficacy of injectable medications are paramount. The industry faces increasing quality expectations and tightening regulatory requirements, particularly concerning particulate and microbial contaminations, which are a leading cause of FDA recalls. The recent update of Annex 1 by the European Medicines Agency’s Good Manufacturing Practices (EMA GMP) underscores the importance of contamination risk mitigation, requiring manufacturers to implement comprehensive contamination control strategies (CCS).

Download the Publication about New Annex 1 Requirements
31 May 2024

These CCS must cover the complete manufacturing process, including suppliers, and must address sterility assurance and particulate contamination.

Aptar Pharma, a leading manufacturer of primary packaging solutions, offers innovative solutions to help pharmaceutical manufacturers meet these new requirements. One such solution is PremiumFill®, an improved manufacturing process for elastomeric closure components that reduces the risk of contamination during production. This process meets the key contamination criteria outlined in the Annex 1 revision, allowing manufacturers to upgrade their operations without requiring regulatory reapproval.

In response to the Annex 1 revision’s requirement for sterile drug manufacturers to demonstrate and check the sterility of their primary packaging, Aptar Pharma offers Ready-To-Use gamma sterilized vial stoppers and syringe plungers. This validated and market-proven sterilization method provides all necessary guarantees and certificates.

To further minimize the risk of introducing extrinsic contaminants during the transfer of components on aseptic filling lines, Aptar Pharma offers components packaged in a variety of Rapid Transfer Port bags. These can be directly connected to the manufacturers’ filling lines, thereby limiting the risk of accidental contamination.

In conclusion, while the Annex 1 revision imposes stricter guidelines on manufacturers, commercially available solutions can help them implement their contamination control strategies and improve operational efficiency. These solutions, such as those offered by Aptar Pharma, are crucial in ensuring patient safety and accelerating market access.

Learn more about Aptar Pharma Expertise
in Injectable Drug Delivery

Find Out More About Injectable Drug Delivery

This Might Also Be of Interest

14 Jun 2024

Vial Stopper Compatibility: Criteria and Testing Methods

Publications, Pharmaceutical, Device Innovations, Market Insights, Product Solutions

Read More
7 Jun 2024

Derisking the Development of Sensitive Injectables

Webinars, Pharmaceutical, Device Innovations, Market Insights, Product Solutions

Read More
31 May 2024

Helping Pharma Manufacturers Meet New Annex 1 Requirements

Publications, Pharmaceutical, Market Insights, Product Solutions

Read More
3 Apr 2024

Advanced Parenteral Closure Solutions: The Perfect Fit Towards Compliance with EMA GM...

Webinars, Pharmaceutical, Innovation & Insights, Market Insights, Product Solutions

Read More
1 2 3 12
Back To Top