EU GMP Annex 1 Guidelines

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.

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.

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.

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.