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.
The actual quantities (g, kg, liters) etc. of ingredient should be stated.
Overage: Supporting data and reason for including the overage shall be enclosed.
The total number of dosage unit per batch must be stated.
Reference EMA Guideline:
Guideline on Manufacture of the Finished Dosage Form
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
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
