特殊样品的编码？

beiwei5du

7.4.3 Verification of Purchased Product
There should be procedures for the approval and release of quality-critical material.
Upon receipt, quality-critical materials should be placed in quarantine and should not be used prior to acceptance. Effective quarantine can be established with suitable identifying labels, signs and/or other manual documentation systems. When quarantine and stock control are managed with computer systems in lieu of a physical stock control, then system controls should prevent the use of unreleased material.
Quarantine may not be feasible for materials supplied via pipelines. In these cases the excipient manufacturer should establish an agreement with the supplier so that they are notified of material that does not meet specification.
Sampling activities should be conducted under defined conditions, in accordance with a defined sampling method and using procedures designed to prevent contamination and cross-contamination.
Quality-critical materials used in the manufacture of an excipient should be tested or otherwise verified prior to use. Verification should include availability and a check of the supplier certificate of analysis and, wherever feasible, at least an identification test. Testing schedules should be organised to separate those tests that are routine from those that are performed infrequently or only for new suppliers.(针对于批准供应商和非批准供应商（比如一些新潜在供应商或者非常规性检测，大家是够有相应的编码规程以区分充分的规范相应的样品编码呢？？）
Bulk deliveries should have additional controls to assure material purity and freedom from contamination (for example dedicated tankers, tamper-evident seals, a certificate of cleaning, analytical testing and/or audit of the supplier).
These procedures, activities and results should be documented.

zysx01234

管理太复杂，是自己找死。

gaojiaoqing

应该有各自的编码方法，以确保追溯性。

beiwei5du

zysx01234 发表于 2016-11-8 14:22
管理太复杂，是自己找死。

管理太灵活，是自己找死，对于这种编码的问题，个人不觉得不是复杂与不复杂的问题。

hongwei2000

能够控制能有追溯即可

86419405

什么是特殊样品