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reprocess and rework

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2022-12-02 / 0 评论 / 0 点赞 / 521 阅读 / 60 字

Reprocessing 重新加工

Reprocessing is taking a material (in-spec or out-of-spec) and reintroducing it to an existing (validated) process.

Rework 返工

Reworking is taking an out-of-spec product and running it through a non-standard process to bring it back into spec. Concurrent validation is required.

reference

API first
ICH Q7
APIC guideline

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