Stratogene Pharma

capa/capa met 0801 001

Today

Active

3

Ready

2

Open Dev.

1

Yield 30d

95.8%

OOS 30d

0.11%

CAPA-MET-0801-001

CLOSED

Linked Deviation: DEV-MET-0801-001

Batch MET-0801 · Metformin HCl 500mg Tablets · Fill Weight

Risk Score

65/100 🟠

Pre-CAPA Risk

🔴 HIGH

Post-CAPA Risk

✅ LOW (92/100)

Created 4 November 2025 by Rajesh Kumar

✓
Created
2025-11-04
✓
Assigned
2025-11-04
✓
In Progress
2025-11-05
✓
Verified
2025-11-30
5
Closed
2025-12-01

Corrective Actions

Fix the current problem — actions already taken or in progress

Action 1COMPLETE

Description *

Owner *

Due Date *

Completed Date

Evidence

📎 Equipment_log_MachineA_Dec01.pdf

Preventive Actions

Stop the problem from recurring — systemic improvements

Action 1COMPLETE

Description *

Owner *

Due Date *

Completed Date

Evidence

📎 Maintenance_schedule_update_Dec14.pdf

QA Sign-off

Root cause has been confirmed and documentedCorrective and preventive actions are adequateEffectiveness check is scheduled with clear targetsResidual risk is acceptable post-CAPAQA Manager approves CAPA for closure

Complete all 5 sign-offs to close this CAPA