Part I, Section B : Product Formula

B1 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, 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

B3 
Attachment of Batch Manufacturing Formula

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

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