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Code · CFR · Title 21 — Food and Drugs · Part 1271 — Human Cells, Tissues, and Cellular and Tissue-Based Products · § 1271.225

§ 1271.225. Process changes.

58 words·~1 min read·/us/cfr/t21/s§ 1271.225·

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Any change to a process must be verified or validated in accordance with § 1271.230, to ensure that the change does not create an adverse impact elsewhere in the operation, and must be approved before implementation by a responsible person with appropriate knowledge and background. You must communicate approved changes to the appropriate personnel in a timely manner.
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