B1.1 Batch Size Please state the manufacturing batch size of the product. |
B1.2 Batch formula A) Active Ingredient Overage
B) Excipient Overage
Please refer to Product Validation- Active Ingredient & Excipient |
B2 Attachment of Batch Manufacturing Formula A batch formula should be provided that includes a list of all components of the product to be used in the manufacturing process, the amounts per unit dose, including overages (if any), and a reference to their quality standards.
Reference EMA Guideline:
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Section B : Product Formula
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