Addressing Significant Hazards Across Multiple Facilities: Best Approach?
We are a company with 7 manufacturing facilities. One of our facilities has identified significant biological and physical hazards in their Preventive Controls hazard analysis. It is basically a "by product" that is transferred to another facility within the company to be used in their finished goods. My concern is this product leaves the plant to go to another facility within our company before these hazards are controlled. Do significant hazards need to be controlled at a facility level or can they be addressed at a company level? Can a plant rely on another plant's monitoring records to prove these hazards are being controlled or reduced through thermal process, metal detection, filters, etc.
In the case of a biological hazard, I think the most responsible thing to do would be to control for that hazard in the facility of origin. Biological hazards increase over time (microbial growth) and spread during handling (contamination). Therefore waiting for the product to be distributed does increase the risk in this process. Physical hazards like foreign material are less difficult to address most of the time, but it would still be harder to do a root-cause-analysis for foreign material found in a product if it's come from a totally different facility even in the same company.
Yes, you can do this. You would want to label or place on accompaning documents "Not processed to control X Hazard" see 21 cfr 117.136
While the FDA is not really enforcing written asurances ( i bleieve it is still a "discretion" requirement), you should also comply with that rule as well to be "safe". Basically a satement from your "Customer" that they are controlling the hazard. details of this are in the CFRs.
https://www.accessda....cfm?fr=117.335
https://www.fda.gov/...110023/download (discretion statement)
Yes, you can do this. You would want to label or place on accompaning documents "Not processed to control X Hazard" see 21 cfr 117.136
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We do this for intermediate materials moved from one facility to another for biological and physical hazards "requires thermal lethality treatment", "requires FM inspection"
We do this for intermediate materials moved from one facility to another for biological and physical hazards "requires thermal lethality treatment", "requires FM inspection"
Just be careful with the wording. I’ve had a FDA rep declare “it’s one of the few times the FDA uses quotes in the regulation.
They were using something similar but less descriptive than what you have. They didnt give them a 483 or anything like that. They Just asked that it be changed and provide proof and added it the inspection report.
Semantics in my opinion.
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I've been in facilities were these products were labelled
"For further processing"
Crystal clear that it is not finished goods