Expertise & Service

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

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