Certificate of Analysis (CoA) Template¶
Version: v1.0
1. Header¶
| Field | Value |
|---|---|
| CoA ID | COA-YYYYMMDD-XX |
| Product | Glucose Test Strips |
| Lot Number | STR-YYYYMMDD-XX |
| Manufacturing Date | |
| Expiry Date | |
| Quantity | __ vials (25/50 pcs) |
2. Materials Confirmation¶
| Layer | Lot | Status |
|---|---|---|
| L1 | Accepted | |
| L2 | Accepted | |
| L3 | Accepted | |
| Enzyme Solution | Released |
3. Key Quality Results¶
| Test | Spec | Result | Status |
|---|---|---|---|
| Enzyme Volume | 3.0 µL ±2% | Pass/Fail | |
| Lamination Alignment | ±0.1 mm | Pass/Fail | |
| Electrochemical Low | Range | Pass/Fail | |
| Electrochemical Mid | Range | Pass/Fail | |
| Electrochemical High | Range | Pass/Fail | |
| Physical Damage | 0 critical | Pass/Fail | |
| Vial Count Accuracy | 100% | Pass/Fail |
4. Environmental Compliance¶
- Production humidity maintained 20% ±2% (Log Ref: ____)
- Temperature 18–25°C (Log Ref: ____)
5. Deviations¶
List any approved deviations impacting lot (ID & disposition):
6. Statement¶
We certify the above lot conforms to internal specifications and is manufactured under controlled conditions.
7. Authorization¶
| Role | Name | Signature | Date |
|---|---|---|---|
| Production Supervisor | |||
| Quality Assurance |
8. Distribution¶
- Original: QA Archive
- Copy: Customer / Regulatory Folder
Revision History: v1.0 Initial release.