Defining “Production start” for yeast: archival strain maintenance media (selective/differential) vs food-grade propagation
We want to document a clear boundary that:
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Archival strain maintenance (isolation/purity confirmation/working slants) is not part of Production, and
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Production begins at the step where culture from the working slant inoculates the first approved food-grade starter medium, after which only food-grade ingredients/approved processing aids are used.
I’m looking for peer input on how others document and defend this boundary for FDA/FSMA and/or GFSI audits, specifically:
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Do you formally classify selective/differential media used for purity confirmation/strain maintenance as archival/lab-only (i.e., not Production materials)?
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What controls and records have been most effective to demonstrate segregation and prevent inadvertent introduction into Production (e.g., labeling, inventory controls, physical separation, transfer SOPs, inoculum volume limits, training)?
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Have auditors/inspectors ever challenged the concept of “incidental carryover” at the inoculation step? If so, what documentation resolved it (e.g., a brief risk assessment, worst-case carryover/dilution calculation, written process boundary statement)?
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If anyone has non-proprietary references (industry guidance, auditor expectations, regulatory interpretations) that support this approach, I’d appreciate pointers.
I am not familiar with your process but I have a question. Why would you not be using food grade materials in your lab? Is there not a source which are both suitable for microbial use and suitable for food? Would it not be easier to confirm this with the suppliers rather than tie yourself in knots?
It might be I'm not understanding your process well enough.
Of course though if there are materials which should not be taking into production (and this happens with other applications) there are ways to help this.
Firstly you need to make it really clear what the rules are, so I would colour code anything not to be taken into production areas to make it 100% clear. E.g. put on a coloured label "lab only" on arrival that's bright and easy to see. I would make sure I could transfer these to the lab without recourse to production.
I'd then write an SOP and Work Instruction, involving the production team and lab teams. Make sure what controls are put in place are workable and ask for more suggestions on how to physically separate and visually manage.
Then assess how you can verify controls are working. Put it into your GMP audits and any leader and supervisor look go sees. Praise people for following the right controls. Do sense checks on whether people understand the "why" etc. Do mass balance traces and audits on a periodic basis so you can see if things are being followed.
I think in that way, this is no different to any other control.