Requirementsforcompany-internalmicrobiologicallabs–Whattoconsider?WhatdotheauditorsoftheIFS,BRCorkGMPaswellastheretailindustrydemand?

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Sep 25, 2019 - Cosmetics

Requirementsforcompany-internalmicrobiologicallabs–Whattoconsider?WhatdotheauditorsoftheIFS,BRCorkGMPaswellastheretailindustrydemand?

The question is repeatedly asked whether it is sensible and efficient to perform microbiological testing of cosmetic end products (batch release), including the testing of raw materials and water, in in-house laboratories or externally.

Besides economic considerations, spatial equipment and personnel resources play an important role. It often turns out that internal testing only seems reasonable from a certain sample volume onwards. Furthermore, a distinction should be made between testing the microbial status and performing preservative stress tests (PST).

Requirements for handling pathogens can be found in the Biological Agents Ordinance (BioStoffV) as well as the Infection Protection Act (IfSG). A central question here is the extent to which an internal laboratory is subject to notification and/or permission obligations with the authorities for handling the respective germs.
 
This question of handling pathogenic germs as well as questions regarding notification and permission obligations are increasingly being asked during audits, e.g., the IFS HPC Standard, BRC, or kGMP, and evidence for this is being requested.
 
Do you have questions on this topic? Further information can be found, among others, in our BAV Information No. 2/2019 "Microbiological Testing of Food, Feed, and Cosmetics in In-House Laboratories – What Requirements Must Be Met?"