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Audit

Welcome back, Rajesh

Here's what's happening on the floor today.

Today2Active3Ready3Open Dev.1Pending ⏳10
Manufacturing Lines
Live status — 08 Jun 2026
Line 1
Solid Dosage — Compression & Filling
● ACTIVE
Active Batch
MET-C-0045
Metformin HCl 500mg Capsules🔵 Capsule
Stage: ⚙️ Filling
Started: 07 Jun 2026, 08:00 IST
Checks: 4 recorded · Pass Rate: 100%
Operator: Priya Sharma
📋 Open Batch➕ Add Check
Line 2
Solid Dosage — Compression & Strip Pack
● READY
Active Batch
IBU-0340
Ibuprofen 200mg Tablets💊 Tablet
Stage: ⚙️ Coating
Started: 02 Jun 2026, 08:00 IST
Checks: 45 recorded · Pass Rate: 100%
Operator: Sanjay Khanna
📋 Open Batch➕ Add Check
Line 3
Coating & Blister Pack
● ON HOLD
Active Batch
PAR-0124
Paracetamol 500mg Tablets💊 Tablet
Stage: ⚙️ Packing
Started: 03 Jun 2026, 06:00 IST
Checks: 3 recorded · Pass Rate: 67%
Operator: Priya Sharma
📋 Open Batch➕ Add Check
Line 4
Capsule Blister & Secondary Pack
● READY
Active Batch
IBU-C-0023
Ibuprofen 200mg Capsules🔵 Capsule
Stage: ⚙️ Packing
Started: 04 Jun 2026, 06:30 IST
Checks: 13 recorded · Pass Rate: 100%
Operator: Sanjay Khanna
📋 Open Batch➕ Add Check
Line 5
Liquid Manufacturing Suite
● ACTIVE
Active Batch
PAR-L-0012
Paracetamol Oral Suspension 250mg/5mL🧪 Liquid
Stage: 🧪 Compounding
Started: 07 Jun 2026, 11:30 IST
Checks: 4 recorded · Pass Rate: 100%
Operator: Priya Sharma
📋 Open Batch➕ Add Check
Avg Yield
GREEN
95.3%
All products
OOS Rate
GREEN
0.09%
2127 checks
Compliance
GREEN
99.1%
Part 11 audit
Open Deviations
1
Attention Queue
5 items
Sorted by severity (CRITICAL first) · Last updated: 08 Jun 2026
🔴 1 Critical🟠 2 High🟡 1 Medium⚪ 1 Low
🔴 CRITICALFacility-wide
Self-inspection overdue
85 days since last inspection. Schedule M requires monthly self-inspection (≤30 days).
Start Inspection →
🟠 HIGHLine 1 / COMP-A
COMP-A calibration due in 15 days
Due 23 Jun 2026. Schedule now to avoid production interruption.
View Equipment →
🟠 HIGHLine 2
Hold approval pending — PAR-0124
Fill Weight OOS (486.2 mg). Awaiting QA decision.
Review Hold →
🟡 MEDIUMLine 1
Deviation Phase II in progress
DEV-MET-0891-002 — Phase II investigation due. CAPA pending.
View Deviation →
⚪ LOWFacility-wide
Audit finding F-2026-06-001 open
MINOR finding from INSP-2026-06-05. Response due within 30 days.
View Finding →
Hold Approval Requests
  • PAR-0124
    Requested by Amit Patel · Fill Weight Check #3 returned 486.2 mg (spec: 490-510 mg). Production stopped pending QA investigati…
    Approve Hold
Golden Batch benchmark

MET-0889 · Metformin HCl 500mg Tablets

View batchOpen Analyser
Batch ID
MET-0889
Product
MET-500-T
Dates
21 May 2026 → 24 May 2026
Yield
96.5%
Zero deviations
MetricCurrent MonthGolden BatchΔVerdict
Yield %96.2%96.5%0.29%Slightly Higher
OOS Rate0.00%0.00% 0%Similar
Avg Cpk0.002.102.10Slightly Higher
Mean Fill Weight112.36 mg109.26 mg3.09 mgSlightly Higher
Deviation Rate0.0%0.0% 0%Similar

Comparison vs trailing 10 batches of MET-500-T. The Golden Batch is the best historical execution and is used as the calibration target for SPC limits.

🏆 Golden Capsule benchmark

MET-C-0042 · Metformin HCl 500mg Capsules

View batchOpen Analyser
Batch
MET-C-0042
Line
Line 1
Dates
28 Apr 2026 → 30 Apr 2026
Yield
98.4%
Zero deviations

Best-yielding capsule batch in the trailing closed-batch window. Used as the calibration target for capsule fill weight SPC limits.

🏆 Golden Liquid Benchmark

PAR-L-0010 · Paracetamol Oral Suspension 250mg/5mL

View batchOpen Analyser
Batch
PAR-L-0010
Line
Line 5
Dates
14 May 2026 → 16 May 2026
Yield
98.1%
Zero deviations

Best-yielding liquid batch in the trailing closed-batch window. Used as the calibration target for liquid pH and fill-volume SPC limits.

Yield & OOS trend (6 months)
Yield 77.8%OOS 0.09%
Equipment performance
Compression Machine A
Compression · Line 1 · Optimal · last PM 28 May
OPTIMAL
Compression Machine B
Compression · Line 2 · Calibration due Jun 8
CAUTION
Coating Pan
Coating · Line 3 · Optimal · pan rotation nominal
OPTIMAL
Bottle Filling Line
Packaging · Bottle · Optimal · induction sealer verified
OPTIMAL
Strip Packing Machine
Packaging · Strip · Maintenance due
CAUTION
Blister Packer A
Packaging · Blister · Optimal
OPTIMAL
Blister Packer B
Packaging · Blister · Optimal
OPTIMAL
Product performance
ProductBatchesAvg YieldOOS RateCpk
Ibuprofen 200mg Tablets
IBU-200-T
4096.3%0.00%0.00Incapable
Metformin HCl 500mg Tablets
MET-500-T
4195.9%0.18%0.00Incapable
Paracetamol 500mg Tablets
PAR-500-T
3796.8%0.20%0.00Incapable
Metformin HCl 500mg Capsules
MET-500-C
1087.5%0.00%0.00Incapable
Ibuprofen 200mg Capsules
IBU-200-C
1097.6%0.00%0.00Incapable
Paracetamol Oral Suspension 250mg/5mL
PAR-250-L
986.5%0.00%0.00Incapable
Ibuprofen Oral Suspension 100mg/5mL
IBU-100-L
897.4%0.00%0.00Incapable
Open Deviations
View all
  • DEV-MET-0891-002
    Fill Weight OOS (485 mg, LSL 490 mg) — repeat investigation
    OpenOpen
Ready for Closure
BatchProductLineStatusYield
IBU-0340Ibuprofen 200mg TabletsLine 2Ready for Closure96%
Review & CloseOpen
IBU-C-0023Ibuprofen 200mg CapsulesLine 4Ready for Closure97.8%
Review & CloseOpen
IBU-L-0008Ibuprofen Oral Suspension 100mg/5mLLine 5Ready for Closure97.3%
Review & CloseOpen
Audit Readiness🇮🇳 CDSCO
71/100🟡 PREP
71%
✅ 3 sections compliant
🟠 6 sections need attention
Next: 05 Aug 2026 (58 days)
Last: 15 Mar 2026 (82/100 ↘)
QMS Coverage
  • Regulatory Philosophy✅
  • Data Integrity✅
  • Validation & Qualification🟠
  • Quality Risk Management🟠
  • Out of Specification (OOS)✅
🔍 Enter Audit Mode →