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Number of Actionable Process Steps

Started by , Yesterday, 03:41 PM
1 Reply

We are a contract manufacturer of dietary supplements and I am re-writing our Food Defense Plan. Our old one is out dated and quite frankly not compliant. Is there a minimum or maximum number of actionable process steps that we should have based on the number of overall production process steps we have?

 

For example - For encapsulation, we have 19 process steps but after going through each one i believe only 3 of them fit the FDA's definition of an actionable process step. 

 

Just looking for some suggestions or guidance

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Have you tried using FDA's Mitigation Strategies Database?

If you find the process step here, it will likely be considered an actionable process step.

 

https://www.cfsanapp...egies/index.cfm

 

This is the GMP Guidance for 2022.

https://www.fda.gov/...load?attachment

 

On page 11 it mentions mitigation strategies that cover all process steps.

(ex: background checks for all employees)

You could mention any of the comprehensive strategies for the 16 steps that you didn't define as actionable.

This was acceptable in my previous audits.


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