Q1A中关于Commitment batches的定义不太明白,望高手指点!
”Commitment batches“
Production batches of a drug substance or drug product for which the stability studies are initiated or completed post approval through a commitment made in the registration application.
指定批次:活性物质或者制剂用于稳定性开始研究的生产批次,或者按照注册申请中的承诺进行生产并经批准的批次。
多谢Vsorrowdc的解释!!!
”Commitment batches“
Production batches of a drug substance or drug product for which the stability studies are initiated or completed post approval through a commitment made in the registration application.
指定批次:活性物质或者制剂用于稳定性开始研究的生产批次,或者按照注册申请中的承诺进行生产并经批准的批次。
多谢Vsorrowdc的解释!!!