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