Stratogene Pharma

capa/capa met 0843 001

Today

Active

3

Ready

2

Open Dev.

1

Yield 30d

95.8%

OOS 30d

0.11%

CAPA-MET-0843-001

CLOSED

Linked Deviation: DEV-MET-0843-001

Batch MET-0843 · Metformin HCl 500mg Tablets · Fill Weight

Risk Score

65/100 🟠

Pre-CAPA Risk

🔴 HIGH

Post-CAPA Risk

✅ LOW (92/100)

Created 12 March 2026 by Rajesh Kumar

✓
Created
2026-03-12
✓
Assigned
2026-03-12
✓
In Progress
2026-03-13
✓
Verified
2026-04-09
5
Closed
2026-04-10

Corrective Actions

Fix the current problem — actions already taken or in progress

Action 1COMPLETE

Description *

Owner *

Due Date *

Completed Date

Evidence

📎 Calibration_cert_MachineA_Mar13.pdf

Preventive Actions

Stop the problem from recurring — systemic improvements

Action 1COMPLETE

Description *

Owner *

Due Date *

Completed Date

Evidence

📎 SOP-COMP-001-Rev2.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