标签数额平衡的问题

绝恋亲纯

按GMP的规定 我们对成品的标签是要进行数额平衡计算的
那么对于原料药生产过程中 我们中间生产步骤的产品 中间品标签是不是也要进行标签的数额平衡了？
求大神解答

kington

一样的要求，体现的是对印刷包装材料的受控管理

jskf_jskf

同意楼上的说法，同样要计数发放，进行物料平衡的管理

ZFZY002

物料平衡是一样的要求

宗徽

药品说明书和标签管理规定（局令第24号）

友友

应该同样计算。

beiwei5du

标签平衡的目的是防止贴错。那么如果按照FDA cGMP(针对于制剂，原理当然适合于原料药），有足够的措施保证的话（比如：对每一个包装贴签进行检查），个人认为其实不需要进行标签数量平衡（中间体和原料药）。
参见：
§211.125   Labeling issuance.

(a) Strict control shall be exercised over labeling issued for use in drug product labeling operations.

(b) Labeling materials issued for a batch shall be carefully examined for identity and conformity to the labeling specified in the master or batch production records.

(c) Procedures shall be used to reconcile the quantities of labeling issued, used, and returned, and shall require evaluation of discrepancies found between the quantity of drug product finished and the quantity of labeling issued when such discrepancies are outside narrow preset limits based on historical operating data. Such discrepancies shall be investigated in accordance with §211.192. Labeling reconciliation is waived for cut or roll labeling if a 100-percent examination for correct labeling is performed in accordance with §211.122(g)(2). Labeling reconciliation is also waived for 360° wraparound labels on portable cryogenic medical gas containers.

小金库

谢谢分享。

有个性的乡巴佬

小金库 发表于 2022-7-23 10:09
谢谢分享。

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