Module 3 - Strategic case studies in practice

22

PART IIB: METHOD OF PREPARATION

1.

Manufacturing formula

Batch Weight (Kg)

Ingredient

195.0

Paracetarrol EP caffeine Anhydrous EP Phenylephrine Hydrochloride EP Starch EP Crosscannellose Sodium NF Sodium Iauryl Sulphate EP Magnesium Stearate EP

16.25 3.25 4.22 3.25 1.30 2.73

226.00

2.

Manufacturing Process

The dry powders are mixed until unifonn and encapsulated using standard rna.chinery.

3.

Validation of Process

The process used is standard for this type of product.