Stratogene Pharma

capa/capa met 0891 001

Today

Active

Ready

Open Dev.

Yield 30d

95.8%

OOS 30d

0.11%

Audit

CAPA-MET-0891-001

IN PROGRESS

Linked Deviation: DEV-MET-0891-002

Batch MET-0891 · Metformin HCl 500mg Tablets · Fill Weight

Risk Score

65/100 🟠

Pre-CAPA Risk

🔴 HIGH

Post-CAPA Risk

✅ LOW (18/100)

Created 5 June 2026 by Rajesh Kumar

✓
Created
2026-06-05
✓
Assigned
2026-06-05
3
In Progress
2026-06-05
4
Verified
—
5
Closed
—

CAPA Context

Linked Investigation

DeviationDEV-MET-0891-002

BatchMET-0891 · Metformin HCl 500mg Tablets

ParameterFill Weight

ClassificationMAJOR

Root CauseEquipment

DispositionCONDITIONAL RELEASE

Closed—

Root Cause Details

Category

Equipment

Confirmed Root Cause

Compression force drift due to 16-day calibration interval. Machine A pressure reduced from target 20 kN causing underfill.

5-Why Analysis

Why 1: Fill Weight below spec (485 mg)
Why 2: Compression force too low (19.6 kN vs 20 kN target)
Why 3: Machine A pressure drifted downward
Why 4: Valve seal wore down over 16 days
Why 5: 30-day calibration interval too long for Machine A

Root Cause: 30-day calibration interval too long for Machine A

Related CAPAs

CAPA-MET-0843-001

CLOSED

Machine A calibration drift — load cell out of tolerance after 28 days.

View →

CAPA-MET-0801-001

CLOSED

Equipment pressure setting drift — turret RPM low.

View →

Effectiveness Tracking

Check Due2026-07-31

Method

Monitor Fill Weight Cpk for next 10 batches on Compression Machine A

TargetZero OOS events, Cpk ≥ 1.76, calibration on 20-day schedule for all 10 batches

AssignedRajesh Kumar

Batches monitored: 2/10

Current Cpk: 1.82

Corrective Actions

Fix the current problem — actions already taken or in progress

Action 1COMPLETE

Description *

Owner *

Due Date *

Completed Date

Evidence

📎 Calibration_Certificate_MachineA_Jun5.pdf

Action 2IN PROGRESS

Description *

Owner *

Due Date *

Completed Date

Evidence

Preventive Actions

Stop the problem from recurring — systemic improvements

Action 1IN PROGRESS

Description *

Owner *

Due Date *

Completed Date

Evidence

Action 2IN PROGRESS

Description *

Owner *

Due Date *

Completed Date

Evidence

Effectiveness Check Plan

Due Date

Assigned To

Method

Acceptance Target

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

Back