Manufacturers - 1
questions about the firms handling of process deviations it may be appropriate to collect the records, and include them in the EIR for future reference, as an example of the firms process deviation handling procedures. If any significant concerns are not resolved before the end of the inspection, fully discuss these items in the EIR and request a review by CFSAN.
[21CFR 108.35(g) and 113.10]
These sections require all operators of retorts, thermal processing systems, aseptic processing and packaging systems, or other thermal processing systems, and container closure inspectors to be under the operating supervision of a person who has attended and satisfactorily completed a school approved by the Commissioner for giving instruction in these operations. In other words, the supervisors of retort operators, and the supervisors of container closure inspectors must have attended and completed a Better Process Control School, not necessarily the actual operators or inspectors.
Investigators inspecting foreign plants should recognize that there is only a very small probability a foreign firm's supervisors of retort operators and container closure inspectors will have attended and completed a Better Process Control School. Therefore, you should attempt to ascertain and document the extent and nature of training in LACF preservation and operations the supervisors have received. The most important aspect, however, is how they do their job and their knowledge of processing requirements.
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