§113.100 修订杀菌过程和生产记录(Processing and production records)

　　�� 113.100 Processing and production records.

　　（a� Processing and production information shall be entered at the time it is observed by the retort or processing system operator, or other designated person, on forms that include the product, the code number, the date, the retort or processing system number, the size of container, the approximate number of containers per coding interval, the initial temperature, the actual processing time, the temperature-indicating device and temperature-recording device readings, and other appropriate processing data. Closing machine vacuum in vacuum-packed products, maximum fill-in or drained weight, or other critical factors specified in the scheduled process shall also be recorded. In addition, the following records shall be maintained:

　　�?� Aseptic processing and packaging systems. Product temperature in the holding tube outlet as indicated by the temperature-indicating device and the temperature-recording device; differential pressure as indicated by the differential pressure recorder-controller, if a product-to-product regenerator is used; product flow rate, as determined by the flow controlling device or by filling and closing rates; sterilization media flow rate or temperature or both; retention time of containers, and closures when applicable, in the sterilizing environment; and, when a batch system is used for container and/or closure sterilization, sterilization cycle times and temperatures.

　　（b� Temperature-recording device records shall be identified by date, retort number, and other data as necessary, so they can be correlated with the record of lots processed. Each entry on the processing and production records shall be made by the retort or processing system operator, or other designated person, at the time the specific retort or processing system condition or operation occurs, and this retort or processing system operator or other designated person shall sign or initial each record form. Not later than 1 working day after the actual process, and before shipment or release for distribution, a representative of plant management who is qualified by suitable training or experience shall review all processing and production records for completeness and to ensure that the product received the scheduled process. The records, including temperature-recording device records, shall be signed or initialed and dated by the reviewer.

　　（c� Records of the accuracy of a temperature-indicating device shall include:

　　�?� A reference to the tag, seal, or other means of identity used by the processor to identify the temperature-indicating device;

　　�?� The name of the manufacturer of the temperature-indicating device;

　　�?� The identity of the reference device, equipment, and procedures used for the accuracy test and to adjust the temperature-indicating device or, if an outside facility is used to conduct the accuracy test for the temperature-indicating device, a guarantee, certificate of accuracy, certificate of calibration, or other document from the facility that includes a statement or other documentation regarding the traceability of the accuracy to a National Institute of Standards and Technology （NIST� or other national metrology institute standard;

　　�?� The identity of the person or facility that performed the accuracy test and adjusted or calibrated the temperature-indicating device;

　　�?� The date and results of each accuracy test, including the amount of calibration adjustment; and

　　�?� The date on or before which the next accuracy test must be performed.

　　（d� Records of the accuracy of a reference device maintained by the processor shall include:

　　�?� A reference to the tag, seal, or other means of identity used by the processor to identify the reference device;

　　�?� The name of the manufacturer of the reference device;

　　�?� The identity of the equipment and reference to procedures used for the accuracy test and to adjust or calibrate the reference device or, if an outside facility is used to conduct the accuracy test for the reference device, a guarantee, certificate of accuracy, certificate of calibration, or other document from the facility that includes a statement or other documentation regarding the traceability of the accuracy to a NIST or other national metrology institute standard;

　　�?� The identity of the person or facility that performed the accuracy test and adjusted or calibrated the reference device;

　　�?� The date and results of each accuracy test, including the amount of calibration adjustment; and

　　�?� The date on or before which the next accuracy test must be performed.

　　（e� Records of all container closure examinations shall specify the product code, the date and time of container closure inspections, the measurements obtained, and all corrective actions taken. Records shall be signed or initialed by the container closure inspector and reviewed by management with sufficient frequency to ensure that the containers are hermetically sealed. The records shall be signed or initialed and dated by the reviewer.

　　（h� Records of this part may be maintained electronically, provided they are in compliance with part 11 of this chapter.

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