Formal dispute resolution: Scientific and technical issues related to pharmaceutical cGMP
by FDA Center for Drug Evaluation and Research
This white paper by the Food and Drug Administration's Center for Drug Evaluation and Research (CDER) provides guidance to manufacturers of veterinary and human drugs, including human biological drug products, on how to resolve disputes of scientific and technical issues relating to current good manufacturing practice (cGMP) requirements. Disputes related to scientific and technical issues may arise during FDA inspections of pharmaceutical manufacturers to determine compliance with cGMP requirements or during the agency's assessment of corrective actions undertaken as a result of such inspections. Disputes may be raised to the Office of Regulatory Affairs (ORA) and center levels. The policies and procedures described cover disputes on scientific or technical issues related to cGMPs for manufacturers of veterinary and human drug products, including related active pharmaceutical ingredients (APIs).
| Published: | 2006 |
| Format: | |
| Length: | 16 pages |
| Type: | White paper |
| Language: | English |
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