FAQ
Drugs

Is it acceptable to use an overage of a drug substance to compensate for degradation during a drug product‘s shelf life?

刊登日期:2019-11-12  |  點閱次數 : 33 次 

First, it should be confirmed that the formulation, dosage form and storage condition for the drug product are appropriate.

Based on the ICH Q8, use of an overage of a drug substance to compensate for degradation during a drug product’s shelf life is discouraged. Any overages in the manufacture of the drug product, whether they appear in the final formulated product or not, should be justified considering the safety and efficacy of the drug product. Information should be provided on the 1) amount of overage, 2) reason for the overage (e.g., to compensate for expected and documented manufacturing losses), and 3) justification for the amount of overage. The overage should be included in the amount of drug substance listed in the batch formula.

In addition, wide range of tolerance limit in assay for the specific ingredients (such as vitamins) is in the Pharmacopoeia.

 

( 中文版)


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