Definition

The finished dosage form (e.g. tablet, injection) containing the drug substance and excipients, ready for use by the patient.

Example

A 10 mg film-coated tablet containing the drug substance and excipients such as lactose and magnesium stearate.

Regulatory source

ICH Q8, ICH Q6A

Common mistakes

Failing to establish in-use stability or compatibility for reconstituted or diluted products.

Inspector question

How do you define and control critical process parameters for drug product manufacture?

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