Part 1, Section B : Product Formula
B1 Batch Manufacturing Formula 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.
Reference EMA Guideline: |
B1.2 Batch formula A) Active Ingredient Overage
B) Excipient Overage |
B2 Attachment of Batch Manufacturing Formula Please attach the manufacturing formula document. |