NextPharma received a successful FDA Inspection at its Waltrop site in Germany. The inspection covered the company's product development services activities, including technology transfer, analytical method validation and stability testing, and contract manufacturing services, including facility qualification and process validation.
The two-part investigation included pre-approval assessment of data/records against the regulatory submission and compliance of the Quality Management System with the FDA six GMP systems. The inspection also confirmed that the approach to facility qualification and risk management was satisfactory.
Bill Wedlake, chief executive officer, NextPharma Technologies, commented, "We are delighted to have received such a positive result at Waltrop and I’d like to commend the site team and the quality specialists who have contributed to this excellent achievement."
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