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zhangy_1977铜虫 (小有名气)
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[求助]
FDA缺陷信中的对照品一致性
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最近看到一个FDA的缺陷信问题，如下。 OBSERVATION 4 Laboratory controls do not include the establishment of scientijfically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity. Specifically, during the establishment o f system suitability for chromatographic analyses, the firm did not prepare or use a second working standard solution (Check Standard Solution) to confirm the potency, accuracy and purity of the working standard solutions (Primary Standard Solution). A single standard preparation was used to determine the potency, accuracy and purity of the active pharmaceutical ingredient in the sample solution. 问下大神，这个怎么做，是用一个对照品，配成两个对照溶液，进行比较？还是用两个对照品分别配成两个对照溶液进行比较啊？第一个对照与第二个对照溶液如何计算比较？ |
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