CordenPharma is pleased to announce the successful completion of two international regulatory inspections at our Plankstadt, Germany facility, conducted by ANVISA (Brazil) and MFDS (Korean Ministry of Food and Drug Safety).
The CordenPharma Plankstadt site recently completed a routine ANVISA inspection for the manufacture of a highly potent drug product, finishing ahead of the planned five‑day schedule. This early conclusion reflects ANVISA’s strong confidence in the site’s GMP systems, operational controls, and safety standards.
The inspection covered highly potent manufacturing areas, laboratories, the warehouse, and supporting technical functions. Inspectors praised the professionalism, technical expertise, and high level of preparedness demonstrated by the CordenPharma Plankstadt teams, enabling a smooth and efficient process.
Given the well‑known rigor of ANVISA inspections, the successful inspection represents a strong endorsement of the site’s quality culture and its robust containment and control strategies for highly potent compounds.
(CordenPharma Photo) Highly Potent Manufacturing at CordenPharma Plankstadt (DE).
One week after the ANVISA visit, the Plankstadt facility also successfully completed a five‑day inspection by the MFDS, focused on the manufacture of a new first-in class highly potent drug product.
The inspection included onsite tours and an in‑depth GMP documentation review covering the warehouse, highly potent manufacturing, engineering, and laboratory areas. This comprehensive approach assessed end‑to‑end quality systems, including engineering controls, documentation practices, and operational compliance.
Despite the demanding scope, the inspection was conducted in a professional and collaborative atmosphere, further confirming the robustness of the site’s GMP framework and its capability to manage complex, highly potent manufacturing processes.
The successful completion of both the ANVISA and MFDS inspections resulted in zero observations, which reinforces CordenPharma Plankstadt’s position as a trusted, high‑quality manufacturing partner with proven expertise in the safe and compliant manufacture of highly potent drug products.
CordenPharma extends its sincere thanks to everyone involved for their outstanding commitment, which continues to strengthen our global reputation for providing superior regulatory compliance.
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