FAQ
Drugs

There are several container closure sizes/fills for one drug product. Can we produce one commercial scale batch of bulk product and then fill or package the bulk product in different sizes of the same container closure system?

刊登日期:2019-11-22  |  點閱次數 : 1301 次 

Yes. The detailed packaging record should be kept of this operation, and the quality of the drug product in different sizes of the container closure system should be evaluated. The quality characteristics, such as wall thickness, closure geometry, surface area to volume ratio, headspace to volume ratio, water vapor permeation rate or oxygen permeation rate per dosage unit or unit fill volume, as described in MOHW 1041408733, Guideline on Stability Testing of Drug Substances and Products, may be taken into account for the assessment. The process evaluation and the stability studies during product development could be applied to ensure the same quality of the drug product in different sizes of the container closure system.

 

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