2 replies to this topic

[mtelander]

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

[AltonBrownFanClub]

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.

Edited by AltonBrownFanClub, 25 July 2024 - 04:45 PM.

[Karenconstable]

Hi mtelander,

 

there is no 'correct' number for actionable process steps, it's entirely possible to have 19 process steps with only 3 fitting the FDA's definition of an actionable process step. 

 

The idea of an 'actionable process step' is a place where a person could add a harmful adulterant to food or ingredient or WIP.  So if you have a mostly closed/inaccessible process, or use solid rather than flowable ingredients, or if you handle small quantities rather than bulk quantities of flowable materials then you won't have many actionable process steps, and that's fine. 

 

If you have checked all 19 steps against the FDA definitions of key activity types (KATs) and documented your decisions (yes/no) then you are on the right track for sure.