A4 : Product Description

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  • State briefly on visual and physical characteristics of the product.
  • For injections packed with diluent, description of the product must include description of the diluent
  • Description must include the appearance after the product is diluted/mixed with water or other proposed diluents(s) (for suspension, powder for injection etc)
  • Explain the markings for tablet, the meaning of the logo, can the tablet be cut into half or not (scoring should suit its dosing)
  • If the scored tablet is not meant to be cut, this should be stated in A4.
  • If capsule, to describe capsule contents
  • Different strengths of tablets should have different sizes. Should state size (mm unit, etc) for each strength of tablet and the size should not be the same.

 

No.

Dosage Form

Description

1.

Tablet

Shape, size, colour, odour, taste, marking, emboss, type of tablet (e.g. coated, uncoated, film, sugar etc.)

2.

Capsule

Shape, size, colour, odour, taste, marking, emboss, coating, content of capsule, type of capsule (e.g.: soft, hard, chewable etc.) 

3.

Liquid

Clarity, type (e.g. solution/ suspension/ emulsion etc.), taste, odour, colour.

4.

Powder

Colour, odour, taste etc.

5.

Pill

Colour, odour, taste, size etc.

6.

Granules

Colour, odour, taste, size etc.

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