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| | M4Q: The CTD - Quality |
 | | The introduction should include proprietary name, nonproprietary name or common name of the drug substance, company name, dosage forms, strengths, route of administration, and proposed indications. |
 | | The name, address, and responsibility of each manufacturer, including contractors, and each proposed production site or facility involved in manufacturing and testing should be provided. |
 | | A batch formula should be provided that includes a list of all components of the dosage form to be used in the manufacturing process, their amounts on a per batch basis, including overages, and a reference to their quality standards. |
| www.fda.gov /cder/guidance/4539Q.htm (7398 words) |
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