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NextPharma’s Waltrop Site Successfully Inspected

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By: Tim Wright

Editor-in-Chief, Contract Pharma

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 ...

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