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§58.81. Standard operating procedures. — Inbound Citations

21 C.F.R. § 58.81

Cited by 1 regulation in release Current.

Citations to §58.81(b)(11)

  • (b) The written standard operating procedures required under § 58.81(b)(11) shall set forth in sufficient detail the methods, materials, and schedules to be used in the routine inspection, cleaning, maintenance, testing, calibration, and/or standardization of equipment, and shall specify, when appropriate, remedial action to be taken in the event of failure or malfunction of equipment. The written standard operating procedures shall designate the person responsible for the performance of each operation.