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When it comes to sterile injectable drugs, maintaining sterility and avoiding product contamination are critical requirements for patient safety. The EU Good Manufacturing Practice (GMP) Annex 1 provides technical guidance on the principles and guidelines of GMP for medicinal products for human and veterinary use. In August 2023, a significant revision of Annex 1 took effect and presents new challenges for drug manufacturers.
You need to be able to monitor and reduce particulates and microbiological contaminants, assure sterility and work towards the use of barrier technologies. Are you ready to implement these changes?
You need to have a robust understanding of the factors impacting CCI so that you can monitor and test each factor over the life of the drug product. Are your processes set up to do this?
E&L have both direct and indirect impacts on product quality and patient safety as the extractable could be toxic and impurities could interact with the drug product. How will you manage E&L to address product quality impacts?
What are your current component quality specifications for particulates, bioburden and endotoxins? Do they need to be tighter?
How will your components and finished drug product be sterilized? How will your components be introduced to the fill/finish line?
Do you fully understand the multiple factors affecting CCI? What monitoring and testing plan is in place over the drug product shelf life to ensure sterility?
Does your supplier have a holistic CCS focused on continual improvement? What documentation is available to support your CCS?
NovaPure® - Highest quality components trusted by approved molecules Learn More
Mitigate risk as you protect lyo and liquid drugs from visible, subvisible particles and unwanted stopper interactions.
Protect your drug with components of superior quality that allow you to choose your preferred/differentiated delivery system.
Optimize syringe performance by reducing plunger variability and reducing the amount of free silicone oil while maximizing quality.
Whether it’s a vial or pre-filled syringe, West has packaging components and systems to help ensure your EU GMP Annex 1 compliance
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