Question on Microbiological Testing of Finished Goods

The Question posed on LinkedIn:

I have a question on microbiological testing of finished goods. We normally do TCP and Yest and Mold, however some customers are saying that pathogenic bacteria test is required after an enrichment is done. Is this really necessary if the PET passes and the TCP and Yest and Mold are less than 10 cfu?”

My reply was this:

“Hi Danushka. and have information that should be useful to you.

There was a followup question asking whether such testing was mandatory so after a little research this was my reply…

Danushka Abeyasekera I cannot give a definitive answer as cosmetics are not my specialty. I do know pharmaceutical creams, ointments and lotions. I would be very surprised if Pseudomonads or Staphylococcus were allowed as as you not want to cause illness in your customers. Candida possibly.

Search the FDA site (if this guidance is relevant to you) and look for Cosmetic Goods Manufacturing Processes. As of 2013, there is a draft guidance. Where “should” is used, that is optional (keep in mine not following guidance typically requires justification) and where “must” is used, that is mandatory.

You may also want to look at ISO 22716: 2007 which is the standard for Cosmetics — Good Manufacturing Practices (GMP) — Guidelines on GMP. This document was last reviewed and confirmed in 2017 so the 2007 version remains the current standard. There is nothing in the ISO that specifically states what to test and what the acceptable limits are. I would be uncomfortable with not testing for the microbes in paragraph 1 of my answer and I would seek additional information from my regulatory body (or bodies). You could ask your customers what reg, standard or guideline they want you to test to. That will allow you to target your search.”