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Supplier Management Procedure

1. Supplier Classification

Class Risk Level Examples Qualification Required
Critical High Fmoc-amino acids, resins On-site audit
Major Medium Solvents, reagents, packaging Document review
Standard Low Lab consumables, PPE Certificate of analysis

2. Qualification Process

  1. Supplier identification and initial inquiry
  2. Document review (CoAs, ISO certs, quality manual)
  3. Sample evaluation (3 lots tested)
  4. On-site audit (for critical suppliers)
  5. Approval and addition to Approved Supplier List

3. Ongoing Monitoring

Frequency Activity
Each receipt CoA verification, visual inspection
Quarterly Quality score calculation (% non-conforming)
Annually Performance review, re-audit (critical only)