B1 - Batch Manufacturing Formula

B1.1 - Batch Size

The total number of dosage unit per batch must be stated.

B1.2 - Batch Formula

Overage: Formula overages must be clearly indicated in quantitative terms and justified in the pharmaceutical development part (Section P2.3)

B2 - Does the product consist of genetically modified organism (GMO)?

*If Yes,

• Specify the details
• Provide supporting document

B3 - Attachment of Batch Manufacturing Formula

*Batch Manufacturing Record (Plant document)

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.

• The actual quantities (g, kg, liters) etc. of ingredient should be stated.
• Overage: Formula overages must be clearly indicated in quantitative terms and justified in the pharmaceutical development part (Section P2.3)
• The total number of dosage unit per batch must be stated.

• The batch formula for the intended batch size should be stated. In case a range of batch sizes is proposed, the range should be stated and the batch formula should be provided for at least the largest and smallest batch sizes.
• When the quantity of an active ingredient to be used is calculated from the actual assay value of the batch of that active ingredient ("factorisation"), this should be stated and justified in the remark column.