B1.1 Batch Size

Please state the manufacturing batch size of the product.

B1.2 Batch formula

A) Active Ingredient Overage

• Active Ingredient Name
• Salt Form
• Strength of Active Ingredient (Quantity unit/ dose)
• Strength Salt-Free
• Source of Active Ingredient (Animal – e.g. Bovine, Porcine, Ovine or Others/ Plant/ Others)
• Form of Substance
• Remarks (if any)
• Status

 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.

• Batch size and quantity per batch (g, kg, liters etc.) of ingredient should be stated.
• Overage: Supporting data and reason for including the overage shall be enclosed.

Reference EMA Guideline:

• Guideline on Manufacture of the Finished Dosage Form