Regulatory Affairs Support
YMC Audits
All core business activities have been audited successfully:
- Silica production and bonding facilities
- BioPro IEX resin manufacturing (polymer-based media)
- YMC-Triart (hybrid silica-based media)
- Laboratory services (at YMC Europe GmbH)
- Glass column production (at YMC Europe GmbH)
Routinely, the following topics are covered within a specific audit plan (subject to a signed NDA being in place):
- Plant tour (ideally based on applicable working procedures)
- Quality Manual/DMF/RSF
- Supply Guarantee/Supply Agreement
- Quality Agreement
- Procurement Documentation
Corresponding certificates will be provided, e.g. with regard to:
- BSE/TSE
- MSDS & CoA
- Leachables/extractables data
- Further data if required
