Unmatched Quality & Compliance in Elemental Impurities Testing
Contaminants, impurities, and residuals can creep into the pharmaceutical and biopharmaceutical supply chain at almost any stage of drug development and manufacturing. Left unchecked, they can derail even the most robust path-to-market, as the eventual products will fail to comply with key regulations – including those set forth in The United States Pharmacopeia Convention (USP) 232 & 233 and The International Council for Harmonisation (ICH) Q3D.
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This is where a trusted analytical partner comes in. Avomeen continues to invest in and deploy a variety of advanced technologies to identify impurities in biopharma products, including ICP-MS, coupled with individualized sample preparation techniques. Our microwave digestion methods allow for digestion of even the most complex matrices, guaranteeing reliable and reproducible limit and quantitative results for submission and release testing. Our elemental impurity identification capabilities are driven by dedicated, trained, and experienced pharmaceutical scientists together with Ph.D. chemists who have decades of combined chemical analysis and regulatory expertise.
What do the 2019 elemental impurities
regulations mean for your pharma business?Learn More Here
Meet Rigid USP 232/233 & ICH Q3D Standards with Flexible Protocols
As of January 1, 2018, pharmaceutical manufacturers are now required to comply with new provisions outlined in USP 232/233, which call for biopharmaceutical manufacturers to ensure that their manufacturing processes are kept free from toxic metals. USP 232 sets limits on the amounts of specific class 1, 2A, 2B, and 3 elements allowed in drug products, while USP 233 defines the appropriate analytical methods for measuring elemental impurities. The USP chapters are globally harmonized with the ICH Q3D guidelines. For the dietary supplements and nutraceuticals industry, guidance on the limits of elemental impurities is found in USP 2232.
Put Our Experts to the Test
Custom Method Development, Tailored to Your Needs and Timelines
Every testing project for elemental impurities is different. Before beginning, our project managers and scientists will meet with you to get a concrete understanding of your needs and the complexities of your project. From there, Avomeen takes a customized approach to method development, using analytical techniques that provide the most accurate results down to the trace levels necessary for your project.
Our scientists have deep expertise in element-specific protocols, method development, and validation. But above all else, Avomeen is a partner. We not only test key products, we strive to transfer knowledge to biopharmaceutical companies on how to implement a smooth production process with strategies that prevent future complications with elemental impurities.
Need an example?Read the Case Study
Experience Our Tailored Approach
Following validation, our customized method is used for sample analysis, generating accurate results in a timely manner. If you have any additional samples later on, we use the previously validated methods to get you results as quickly as possible. Standard turnaround times are about 20 business days, but we strive to be flexible and able to follow a timeline that works for you and your team.
Tracking Down the Source of Elemental Impurities
With the unrivaled knowledge, advanced equipment and scientific expertise available at Avomeen’s laboratory, our scientists can perform qualitative screening and quantitative assays on everything from raw materials all the way to final product.
Impurities can come from sources such as:
- Water used in the manufacturing process
- Residue left on equipment
- Containers or closures for products
- Active pharmaceutical ingredients (APIs)
- Excipients (inactive or other ingredients)
The team at Avomeen will help you develop quality control checks such as batch-to-batch testing, refined development methods, and analysis of supplies from raw material suppliers that will minimize elemental impurities in your product and production processes.
Do you have questions about elemental impurities testing?Check out our FAQ to Learn More
Implementing Risk Assessment
Ongoing risk assessment helps define and refine processes for controlling and preventing elemental impurities. The Avomeen team is experienced in the risk-based approach to compliance with elemental impurities regulations, and our expertise in both testing and consulting can help you maximize the effectiveness of your risk assessments.
The FDA also mandates that applications for new products are accompanied by a risk assessment summary for elemental impurities. To remain in compliance with the mandate, previously approved pharmaceutical products must also be submitted with documentation on changes in controls. Even if no changes take place, the FDA still encourages manufacturers to deliver an annual risk assessment summary.
It’s All about the Follow-Up
Avomeen works above the standard on every new project that comes through our doors. We are not just the analysts on elemental impurity identification projects; we are also the consultants.
Once impurity identification is complete, our team takes advantage of readily available scientific expertise to troubleshoot and refine manufacturing processes and techniques to provide a complete solution.
Why Partner with Avomeen?
Decades of experience, the capability to tailor protocols and study designs, and a readiness to take on complex and non-routine analyses results in our ability to offer a comprehensive, all inclusive-solution to our clients.
See how our approach can help transform your goals into real solutions.