Page 53 - 总厂实用英语手册电子书2.0

Investigation should be carried out to identify the root cause of the OOS.

（19）跟踪（结果、效果等）
QA should follow up the implementation of CAPAs.

（20）影响.（质量、效果等）
a. The process change did not affect the product quality.
b. The product quality was not affected due to the process change.
c. The process change had no influence on the product quality.
（21）质量对比

Quality comparison before and after change should be carried out.
（22）包括（但不限于）

Elements to be considered within a documented CCS should include (but are not limited
to): …
（23）持续（稳定性考察、工艺验证）
On-going/continuous stability study/ process verification

（24）保留/保存…长时间
Batch records should be kept/retained for 1 year after expiry date or 5 years after release date,
whichever is longer.
（25）负责…

a. QC takes the responsibility of collecting and organizing the data of quality control involved
in product quality review and providing the summary of the results.
b. QA is responsible for drafting quality management related procedures.
c. Warehouse is in charge of material receiving, storage and distribution.
（26）参与…；涉及；卷入

Related departments should involve in the final decision of reprocessing/ reworking/recovery.

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