The Kymanox Quality Control (QC) team provides knowledge and expertise to ensure that you align your practices to the revised European Union (EU) GMP Annex 1, a guidance document for the manufacture of sterile medicinal products.
What is EU GMP Annex 1?
EU GMP Annex 1 is a guidance document for the manufacture of sterile medicinal products that was recently revised and published on 25 August, 2022. Even if you currently do not have product approved by the EU, US FDA leaders have already indicated a desire to align with these standards. Adhering to Annex 1 requirements can help you improve product quality and reduce time and resources spent on remediating sterility and contamination-related issues.Explore More
Kymanox Areas of Expertise
Kymanox has expertise in aseptic processing, microbiology, environmental monitoring, and contamination control, making us uniquely positioned to succeed in helping our clients adhere to the revised Annex 1 requirements for the manufacturing of sterile medicinal products. Kymanox can help carry out risk assessments, assess root cause behaviors, establish an effective Corrective and Preventive Action (CAPA) system, set-up investigation procedures, and update procedures in the case of arising issues.Explore More
Kymanox and our QC experts can help you identify and close gaps to align with the revised Annex 1 and ensure that your processes minimize contamination-related risk. We can help author a document to outline the necessary policies and procedures for contamination control, develop and implement training on the new guidelines of Annex 1, and help you implement smarter testing with documented risk-based sample plans that can improve efficiencies without sacrificing quality.Explore More
Full Range of Services
Kymanox holds a 360° view of all quality monitoring services and supports these services with additional capabilities such as Quality Assurance, Auditing, CMC, Analytical Sciences, Regulatory Affairs, and more.Explore More
Meet our Quality Control Experts
Jaime Rain, MMB
Markets That Benefit from Our Quality Control Solutions
Our experts understand the interaction between devices and drug products. Our experience includes injectables, nasal, respiratory, and more.
Biologics & Cell and Gene Therapy Services
We understand why “the product is the process” and how to implement solutions to your unique challenges.
Drug development is constantly evolving with new regulations and technology. We stay up to date to maintain your compliance.
The Kymanox Quality Control Difference
We ensure your Quality Control needs are not only right for your company but also aligned with regulatory expectations by blending our hands-on, practical quality control experience with other functional capabilities.
"Right First Time” Execution
Our branded methodology, Ideal Knowledge TransferTM, combines technical project management, fundamental engineering practices, quality and regulatory expertise, and business acumen.
Proven Broad Expertise
Our team of experts is focused on life sciences with extensive experience across drug and device development. No matter your challenge, we can help you conquer it.
Flexibility & Agility
At Kymanox, we make it easy for clients to get the solutions they need, when they need it. Clients tell us our flexibility is one of the key reasons they keep coming back.
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