I’m currently looking into regulatory requirements for product contact parts - specifically materials certification for SS, nylon etc. I’m aware of what is generally expected for minimum requirements such as 316 for product contact SS or compliance with 21 CFR Part 177 and 2002/72/EC for polymers, however what I’m looking for is references to whether batch specific material certificates are expected.
Can anyone point me in the direction of EU/US regulations (or guidelines such as ISPE GEP) that might clarify this?
Also, what are people’s views on conformity certification for materials, would you also expect EN10204 certs from suppliers and, if so, to what level (e.g. 2.1)?
Any opinions would be appreciated. Thanks.