Material Certificates for Commissioning

[startupbiotech]

Does anyone know if there is a specific FDA requirement for Material Certificates on product contact surfaces and instrumentation? I know its industry standard, but my manager is asking for a document that stipulates this (young company).Thanks.

 

[TSeener]

Hi,
I hope that this helps. The FDA uses and refers to the applicable CFR's for the manufacture of food and drugs, Title 21. The applicability and safety of a product contact material is covered by a number of different sections, and it is based upon the type of material. Please use the FDA's web based search of all of Title 21 to identify the sections that are applicable for you.

(

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm)

Now, the need for "material certifications" is not called out, so I have seen where clients will use vendor literature or product markings as a means of proof of material. I would strong discourage that approach though, as the material certifications are a widely accepted method. Hope that this helps.

Best Regards,

TSeener