We’re a yeast manufacturer and are tightening our FSMA/GMP documentation around where Production begins versus what we consider archival strain maintenance / working culture maintenance.
We perform isolation/purity confirmation and working culture preparation (e.g., plates and working slants) using selective/differential microbiological media in a controlled lab environment. These materials are not introduced into production vessels as ingredients/processing aids; the only interface is the inoculation transfer from a working slant into the first food-grade starter medium, followed by large dilution through propagation.
We want to document a clear boundary that:
-
Archival strain maintenance (isolation/purity confirmation/working slants) is not part of Production, and
-
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:
-
Do you formally classify selective/differential media used for purity confirmation/strain maintenance as archival/lab-only (i.e., not Production materials)?
- C
-
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)?
-
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)?
-
If anyone has non-proprietary references (industry guidance, auditor expectations, regulatory interpretations) that support this approach, I’d appreciate pointers.
Thanks in advance!
