3 replies to this topic

[mtelander]

We are a dietary supplement manufacturer, and we have an onsite (segregated) maintenance area to fix our in-house equipment. Our auditor with SQC has asked why our Maintenance Shop is not included in the Master Sanitation Schedule. We have never been asked by any other regulatory body, including FDA, to have that area included because we have an Equipment and Utensils Cleaning SOP which is mentioned in CFR 21 Part 111 Subpart D, anyone have any guidance?

[kconf]

It needs to be included in the MSS. You could be contaminating production area by walking through dirty workshop floors with foreign materials (metal shavings, wooden chips, glass etc.). 

 

You can decide the frequency based on risk, just keep everything documented. 

 

Good luck! 

[SQFconsultant]

I would say you are lucky that he/she just inquired and did not jig you for it. It needs to be on your MSS.

[jfrey123]

Unless the maintenance shop is wholly detached, it should be on MSS for at least general cleaning like your storage areas.  Any equipment returning from maintenance should be fully washed and sanitized in a designated area before returning to production.