Manufacturers - 1

[Previous Page] [Table Of Contents] [Next Page]

---

recognized processing authority, it may be necessary to obtain and review the following additional information. However, do not request this information unless you are instructed to do so by your supervisor:

1. Individual's name;
2. Individual's work affiliation (e.g., consultant, university, firm's employee, etc.);
3. The individual's academic and industrial experience related to thermal process work;
4. General procedures used to establish processes and/or evaluate deviations, such as an overall experimental plan for development of data, factors and variables considered, and range of experiments used;
5. Details of actual experimental methods used, including heat penetration and distribution data and microbiological data when appropriate;
6. Protocol for making conclusions based on experimental data;
7. The F0 value (a measure of lethality) judged necessary to destroy spores of Clostridium botulinum in each product under consideration and the method of calculating the F0 value;
8. The equipment used to perform the experiments including manufacturer, model number, state of repair, and other pertinent data;
9. The accuracy of the test instruments and other equipment, and the records showing that the instruments were routinely calibrated with an accurate standard;
10. Any other facts which have a bearing on the adequacy of the evaluations. where a processing authority who is not generally recognized as competent is involved, the EIR endorsement should specifically request a review of the information and data presented on the evaluation of the process deviations.

This information along with the EIR and all documentary materials (eg: recorder charts, processing records, etc.) should be forwarded by your district to the CFSAN for evaluation. In those cases where a processing authority who is not generally recognized as competent is involved, the EIR endorsement should specifically request a review of the information and data presented on the evaluation of the process deviations.

If a firm is under an order of need for a temporary emergency permit (see Emergency Permit Control Section), they are prohibited from distributing any products in interstate commerce until they obtain a permit, or until they receive advance written approval from FDA (21CFR 108.12). CFSAN will grant approval for product distribution into interstate commerce only upon an adequate demonstration that such food is free of microorganisms of public health significance. In those instances in which processing and production records are complete and there is no indication of the entry of potentially inaccurate information, FDA requires that all of the records for each lot in the possession of the processor be reviewed by a competent processing authority to identify deviations from the scheduled process, and that each deviant process be evaluated for public health safety. If evidence indicates previously distributed product may pose a potential health hazard, FDA may also require record review for all production lots which may be in interstate commerce. The results of these reviews and evaluations must be contained in a written document in a manner which certifies that all processing records for each production lot have been properly reviewed.

In the past CFSAN, has been amenable to other arrangements, by which another person (properly qualified) reviews the records, and then sends them to the processing authority for evaluation. Because these products are released in writing for distribution, CFSAN is very particular about the adequacy of record review and process evaluation.

CFSAN may also require additional heat penetration or heat distribution studies in cases where heating data does not encompass a certain critical factor, or where retort piping has been changed.

PROCESS DEVIATIONS
(21 CFR 113.89)

21CFR 108.35 (d) and (e) requires LACF processors to notify FDA of instances of spoilage, process deviation, or possible contamination with micro-organisms, the nature of which indicates potential health significance when any lot of such food in whole or in part, has entered distribution in interstate commerce.

Each processing deviation must be detected and properly handled by the processor. Processing authorities often advise processors as to whether or not a processing problem must be evaluated as a processing deviation. They serve an important role in assisting plant management in minimizing processing deviations and their causes. However, ultimately the processor is held accountable for the proper handling of processing deviations.

21CFR Section 113.89 requires that whenever any thermal process is less than the scheduled process or when critical factors are out of control for

[Previous Page] [Table Of Contents] [Next Page]