Outsourcing Quality Checklist¶
Quality Assurance for Peptide Contract Manufacturing¶
Pre-Contract Assessment¶
| Check | Details |
|---|---|
| Supplier certification | ISO 9001, GMP (if applicable) |
| Manufacturing capabilities | Scale, equipment, purification |
| Analytical capabilities | HPLC, LC-MS, AAA, endotoxin |
| Reference customers | Check with existing clients |
| Quality agreements | Define roles and responsibilities |
Specification Agreement¶
Ensure the contract includes:
- Purity: HPLC area %, acceptance criteria
- Identity: MS confirmation method and tolerance
- Content: Peptide content range (e.g., 70–90%)
- Impurity limits: Maximum single and total impurities
- Water: Karl Fischer limit
- Residual solvents: ICH Q3C limits
- Counterion: Target acceptable range
- Appearance: Visual criteria
- Packaging: Vial type, closure system
- Shipping: Condition, documentation
Batch Documentation Requirements¶
| Document | Purpose |
|---|---|
| Manufacturing batch record | Traceability |
| In-process control records | Step-by-step verification |
| Raw material COA | Starting material quality |
| Analytical test results | Product quality evidence |
| HPLC chromatograms | Raw data traceability |
| MS spectra | Identity confirmation |
| Stability data | If requested |
| Deviation reports | Any non-conformance |
Audit Checklist¶
Manufacturing¶
- Equipment qualification (IQ/OQ/PQ)
- Cleaning validation between campaigns
- Environmental monitoring records
- Raw material storage and handling
- Process flow and segregation
Quality Control¶
- Method validation status
- Reference standard management
- Out-of-specification (OOS) procedure
- Stability program
- Equipment calibration
Quality System¶
- Change control procedure
- Deviation/CAPA system
- [ 】 Supplier qualification program
- Training records
🔗 Related: COA Understanding | Supplier Qualification | How to Source Peptides from China | Custom Peptide Synthesis at RPL