Clinical applications - MACS GMP Products - MACS GMP Quality - Extensive QA and QC

Extensive QA and QC

Extensive quality assurance (QA) and quality control (QC): MACS® GMP Products are manufactured and tested under a certified ISO 13485 quality system. Stringent quality control tests are performed.

The product-specific documentation includes:

  • Package Insert
  • Batch-specific Certificate of Analysis (CoA) including animal component free statement
  • Certificate of Origin (CoO)/TSE (transmissible spongiform encephalopathies)
  • Product Information File (PIF) and/or Master File cross reference for select products

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Miltenyi Biotec Inc.
Phone: +1 800 FOR MACS
Fax:+1 877 591 1060
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EBMT 2018 Symposium

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