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¶
- Supplier identification and initial inquiry
- Document review (CoAs, ISO certs, quality manual)
- Sample evaluation (3 lots tested)
- On-site audit (for critical suppliers)
- 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) |