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Contamination control is no longer a regional expectation. Regulators worldwide are aligning on common standards for sterile manufacturing. The EU Good Manufacturing Practice (GMP) Annex 1 is an international benchmark influencing frameworks around the world. Regardless of location, when it comes to sterile injectable drugs, maintaining sterility and avoiding product contamination are critical requirements for patient safety.
To build a CCS, drug manufacturers are expected to conduct studies to monitor and/or reduce particulate and contaminant levels, assure sterility, and work towards the use of barrier technologies.
Maintaining CCI requires understanding of packaging design, component quality, process capability, validated testing, stability confirmation, and lifecycle governance.
It is an important expectation to document evidence that E&L risks are understood and monitored to ensure product quality and patient safety.
What are your current component quality specifications for particulates, bioburden, and endotoxins? Do they need to be tighter? Consider our premium NovaPure® components with best-in-class levels of quality, performance, and risk mitigation.
How will your components and finished drug product be sterilized? How will your components be introduced to the fill/finish line? West’s analytical testing services can support your sterilization process validation.
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? West provides testing and analysis to help ensure CCI and performance based on robust CCI data.
Does your supplier have a holistic CCS focused on continual improvement? What documentation is available to support your CCS? West's trusted quality reputation positions us to help you meet evolving global regulatory needs.
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 prefillable syringe, West has packaging components and systems to help ensure your EU GMP Annex 1 compliance
A CCS is a documented, risk-based framework that connects all potential sources of contamination and the controls in place to manage them. Under Annex 1, drug manufacturers must extend CCS to include their packaging supply chain; therefore, West as a supplier must demonstrate its own CCS. Suppliers must be able to show that their facilities, processes, people, materials, packaging, sterilization activities, and quality systems are controlled in a way that supports the pharmaceutical drug manufacturer’s sterility assurance and product quality requirements.
The 2022 revision of EU GMP Annex 1, effective August 2023, expanded the guideline from 16 to 59 pages and introduced a mandatory, holistic CCS as the central requirement. It shifted from a prescriptive checklist approach to a risk-based, outcome-focused framework for sterile manufacturing. More recently, there has been a convergence of key initiatives, guidelines and standards set forth by International Council for Harmonization (ICH), EU GMP Annex 1, Pharmaceutical Co-Operation Scheme (PIC/S) and the World Health Organization to promote and strengthen global consistency and best practices.
Annex 1 section 8.2 requires primary packaging components to be cleaned using validated processes to ensure particulate, pyrogen, and bioburden contamination is appropriately controlled. Suppliers must provide quality data supporting manufacturer CCS submissions. Watch our video on Annex 1 guidelines to know more about the West perspective.
Alignment with Annex 1 requires establishing a holistic, risk-based CCS covering the full manufacturing environment and supply chain, implementing barrier technology where required, and maintaining rigorous documentation across all contamination control activities. Learn more in West’s blog on Annex 1 contamination control guidelines.
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