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Audit

Welcome back, Rajesh

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

Today1Active2Ready2Open Dev.1
Avg Yield
GREEN
95.8%
All products
OOS Rate
GREEN
0.11%
1867 checks
Compliance
GREEN
99.1%
Part 11 audit
Open Deviations
1
Compliance Alerts
Self-inspection overdue — 85 days since last inspection.
Schedule M requires monthly self-inspection.
Start Inspection →
COMP-A calibration due in 15 days — 23 Jun 2026.
Equipment calibration schedule.
View Equipment →
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

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

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.

Yield & OOS trend (6 months)
Yield 83.5%OOS 0.11%
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
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%
IBU-C-0023Ibuprofen 200mg CapsulesLine 4Ready for Closure97.8%
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)
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