包装材料物料平衡为100%？？

374339475

nikonpro 发表于 2017-7-7 13:20
怎么可能是100%呢，有的企业会出现员工偷物料情况。

你可别闹，这种情况不应该出现，至少不能体现吧

beiwei5du

在FDA cGMP中确实也未要求一定是100%，也是允许一定的范围的narrow preset limits based on historical operating data，超过这个范围才进行相应的评估调查。但是具体这个范围如何制定还是需要进行深入了解的。§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.

薛启荣

物料平衡是指你理论用量/产量与实际用量/产量之比，你工序开始的时候就要核查物料数量，生产完成后核查物料平衡，符合要求的才能结束。跟供应商没一毛钱关系。
补充强调下，物料平衡是在生产现场进行的。比如你包装，开始的时候第一步就要核实你领用的物料数量....

每驿必通

nikonpro 发表于 2017-7-7 13:20
怎么可能是100%呢，有的企业会出现员工偷物料情况。

员工偷料这理由，很精辟

wmxwh

可以设定一个范围