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Quality System
 

  • On average, Asymchem is audited at least once a month by QA representatives from major western clients. Asymchem has never failed a QA audit and maintained a 100% first time passing rate.

  • ◆　API: ICH Q7A compliant at all Asymchem sites
  • ◆　Drug product: ICH Q10 and 21CFR parts 210 & 211 (complete by Dec 08)
  • ◆　Release: raw material, intermediates & final Products
  • ◆　Batch Record Review
  • ◆　Change Control
  • ◆　CAPA
  • ◆　Deviation/OOS investigation
  • ◆　Document retention and archives
  • ◆　CoA review and approval
  • ◆　QA present in every shift, 24/7
    • 600 Airport Blvd. Suite 1000 Morrisville, NC 27560 USA Fax:(919)468-3916
    Copyright ©2008 Asymchem Laboratories Inc.All rights reserved.