Support and Services
Bulk Resins Support
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 adaption’s that customers deem relevant in their individual working environment.
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
- Other solids data relevant to the customer
YMC will gladly showcase premium quality features to guest visitors and with prior information a complete tour of our manufacturing facilities – guaranteed.