FAQ
Drugs

If submitted application contains a drug product packaged in various sizes of plastic bottles, are technical documents related to each packaging size of drug product required at the RTF stage?

刊登日期:2021-11-17  |  點閱次數 : 336 次 

Yes, technical documents related to each packaging size are required. The batch packaging record for each packaging size should be provided at the time of submission (a master batch record including package step and the weighing sheet could be provided instead of the batch record). In addition, according to Chapter 3 Design of Stability Study of “Guideline on Stability Testing of Drug Substances and Products”, design of a stability study should consider all factors, and the stability study then be performed accordingly. Therefore, the stability results of different packaging sizes in plastic bottles should be provided.

 

(中文版)


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