Retort Records Requiremnts (21 CFR 113.100)

21 CFR 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:

 (1) Still retorts.

  • time steam on
  • time temperature up to processing temperature
  • time steam off
  • venting time and temperature to which vented (steam retorts only)

 (2) Agitating retorts

  • Functioning of condensate bleeder
  • retort speed
  • when specified in the scheduled process, headspace, consistency, maximum drained weight, minimum net weight, and percent solids.

(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) Copies of all records provided for in this part…. shall be retained at the processing plant for a period of not less than 1 year from the date of manufacture, and at the processing plant or other reasonably accessible location for an additional 2 years. If, during the first year of the 3-year record-retention period, the processing plant is closed for a prolonged period between seasonal packs, the records may be transferred to some other reasonably accessible location at the end of the seasonal pack.

 (d) Records of this part may be maintained electronically, provided they are in compliance with part 11 of this chapter (Electronic records; Electronic signatures).



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