Stratogene Pharma
traceability/cpv
Today
Active
3
Ready
2
Open Dev.
1
Yield 30d
95.8%
OOS 30d
0.11%
CPV Trending
Continued Process Verification — parameter health over time.
Cpk Trend (last 30 batches)
⚠️ Cpk trend declining: 1.85 (Mar) → 1.76 (Jun). At current rate, Cpk may breach 1.33 in ~8 batches.
Parameter Summary (6 months)
| Parameter | 6m Avg Cpk | Trend | OOS Events | Status |
|---|---|---|---|---|
| Fill Weight | 1.76 | ↘ Down | 3 | 🟠 WATCH |
| Hardness | 1.65 | → Flat | 0 | ✅ OK |
| Weight Gain | 1.58 | → Flat | 0 | ✅ OK |
| Tablet Count | 2.1 | ↗ Up | 0 | ✅ EXCELLENT |
Schedule M / FDA 211.192 requires Cpk ≥ 1.33 for all CPPs. Fill Weight is trending toward minimum acceptable. Annual Product Review (APR) due: December 2024. (6 SPC reports filed.)