库存盘点中的物料平衡

beiwei5du

(c) An individual inventory record of each component, drug product container, and closure and, for each component, a reconciliation of the use of each lot of such component. The inventory record shall contain sufficient information to allow determination of any batch or lot of drug product associated with the use of each component, drug product container, and closure
上文选自§211.184   Component, drug product container, closure, and labeling records.
那么这么说来大家是否对物料(component)的每批做物料平衡呢？

beiwei5du

444. Many comments addressed 211.184(c).  Most agreed that an inventory
record and reconciliation for drug product components was appropriate, but
objected to inventory records and reconciliation for drug product containers and
closures.  Others contended that inventory records, but not reconciliation, were
also appropriate for drug product containers and closures.  Arguments were
primarily that recordkeeping to this extent was unnecessary, burdensome, and not
current practice.  Some comments were concerned that extensive records and
reconciliation would be required for packaging materials such as cotton filler
material used in packaging tablets and capsules.  Several comments recommended
changes in the proposed language that would clearly require that the inventory
record be sufficient to establish the batch or lot of drug product in which
component, drug product container, and closure are used.
     The Commissioner has reconsidered the need for individual inventory records
and reconciliation of the use for components, drug product containers, and
closures.  He finds that individual inventory records are necessary to provide
an adequate history regarding the use of components, drug product containers,
and closures.  To clarify the intent that such inventory records are intended to
allow for determination as to the batch or lot of drug product associated with
the recorded inventory, the Commissioner is modifying the proposed wording in
this section (211.184(c) and in 211.188(g)).
     The Commissioner agrees with the comments that reconciliation of the use of
each lot of drug product container and closure should not be required.  Although
there are instances where such reconciliation could be valuable to the drug
manufacturer, it should not be mandatory for all drug products and all drug
manufacturers.  The CGMP regulations elsewhere provide considerable control over
the approval and use of drug product containers and closures.  Because of the
more critical nature of the ingredients on the other hand, each drug product
component must be inventoried and its use reconciled in order to provide added
assurance of product integrity.
     The Commissioner emphasizes that this section does not pertain to all
packaging materials, but only drug product containers and closures.  Thus,
individual inventory records for packaging materials such as cotton filler and
package liners are not required under this section, although records regarding
the receipt, examination or testing, and disposition for packaging materials
generally are required in 211.122, particularly in paragraph (c).

beiwei5du

按照USA FDA的意思针对于制剂要求components必须做到每批的物料平衡，而针对于container and clisure和包材则未硬性要求.container and closure可以仅有台帐即可，以追溯其使用。

xqliu

现在的批记录都有全部物料的平衡，而且检查时也是关注重点。

beiwei5du

xqliu 发表于 2017-8-8 06:54
现在的批记录都有全部物料的平衡，而且检查时也是关注重点。

这里主要是指仓储系统的每个产品的每批的物料平衡，而非生产阶段的物料平衡，两则是不一样的

yuxuan123456

进来学习下

xqliu

beiwei5du 发表于 2017-8-8 10:30
这里主要是指仓储系统的每个产品的每批的物料平衡，而非生产阶段的物料平衡，两则是不一样的

您聪明，物料平衡是全过程的，对吧

beiwei5du

xqliu 发表于 2017-8-19 13:41
您聪明，物料平衡是全过程的，对吧

比如，我共计254kg库存，我领了85kg，那么在生产中我是计算这85kg的物料平衡，而不会去涉及到全部的254kg(比如储存过程中的损失，或者称料过程中的损失),我是这样理解的。

xqliu

beiwei5du 发表于 2017-8-19 15:29
比如，我共计254kg库存，我领了85kg，那么在生产中我是计算这85kg的物料平衡，而不会去涉及到全部的254kg ...

对的，有库损的与生产消耗无关的。

wsx

beiwei5du 发表于 2017-8-7 22:21
444. Many comments addressed 211.184(c).  Most agreed that an inventory
record and reconciliation f ...

请问，上述comment,引用的是那篇指南？谢谢