After approval and marketing of a pharmaceutical product, significant changes may be made in manufacturing the bulk drug substance.
药物制剂的批准和销售之后，生产散装的原料药方面可能会发生大的改变。
This would be particularly true for the bulk drug substance manufacturer where reactors and centrifuges and piping between such large equipment can be sampled only using rinse solution samples.
尤其对那些原料药生产商来说，反应物，反应堆或设备间的管道系统可以只是用冲洗溶液样品取样，这样做就很正确了。
This is particularly important for the foreign sterile bulk drug substance manufacturer where time is limited.
当时间有限时，这对国外无菌原料药的生产厂家特别重要。
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