Expertise

Expertise & Service

Regulatory Affairs Support

Since its inception in 1980, YMC has frequently been subjected to a variety of audit formats by major companies with periodical re-audits, specifically from pharmaceutical and/or biotech customers.

 

As all YMC processes and working procedures are thoroughly monitored and documented, YMC always has been in perfect condition to prove full compliance with the requirements. In addition, YMC consistently provides total responsiveness to suggestions for specific adaptions that customers deem relevant in their individual working environment.

 

As of today, numerous audits on all core business activities have been completed successfully:

    • Silica production and bonding facilities
    • YMC-BioPro manufacturing (polymer-based media)
    • YMC-Triart (hybrid-style media)
    • Preparative LC-systems and columns
    • Laboratory services (at YMC Europe GmbH)
    • Glass column production (at YMC Europe GmbH)

and YMC continues to actively encourage customers’ requests for their individual inspection opportunity.

 

Routinely, the following topics are covered within a specific audit plan (subject to a signed NDA being in place):

  • Corporate information
  • Plant tour (ideally based on applicable working procedures)
  • Quality Manual
  • Drug Master File
  • Regulatory Support File
  • Change Control
  • Business Continuity Policy
  • Supply Guarantee/Supply Agreement
  • Quality Agreement
  • Procurement Documentation.

 

Corresponding certificates will be provided, e.g. with regard to:

  • BSE/TSE
  • Leachables/extractables
  • Stability data
  • Material Safety Data Sheets
  • Certificates of Analysis
  • Pest control
  • Asbestos
  • Conflict minerals
  • Other solids data relevant to the customer.

 

YMC will gladly showcase premium quality features to guest visitors – guaranteed.

 

Related Categories

Contact

  • Dr. Anja Bräutigam
  • Head of Laboratories
  • ph. +49 (0)2064 427-263