§1271.220. Processing and process controls. — Inbound Citations

21 C.F.R. § 1271.220

Statutory Authority

Cited by 2 regulations in release Current.

21 C.F.R. § 1271.150(b)(6)

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(6) Requirements relating to processing and process controls in § 1271.220;
21 C.F.R. § 1271.230(a)

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(a) Where the results of processing described in § 1271.220 cannot be fully verified by subsequent inspection and tests, you must validate and approve the process according to established procedures. The validation activities and results must be documented, including the date and signature of the individual(s) approving the validation.