golden batch analyser
Audit

Golden Batch Analyser

Compare any batch against the Golden standard.

MET-0889
GOLDEN STANDARD
Batch ID
MET-0889
Dates
21 May 2026 → 24 May 2026
Product
Metformin HCl 500mg Tablets
Operator
Priya Sharma
Equipment
Line 1 · Compression
Yield
96.5%
OOS Count
0
Deviation Count
0
Cycle Time
4 days
Total Checks
14 (all PASS)
Cpk (Fill Weight)
1.95
Quality Score
100/100
MET-0891
UNDER REVIEW
Batch ID
MET-0891
Dates
01 Jun 2026 → 04 Jun 2026
Product
Metformin HCl 500mg Tablets
Operator
Priya Sharma
Equipment
Line 1 · Compression
Yield
97.6%+1.1%GREEN
OOS Count
1+1RED
Deviation Count
1+1RED
Cycle Time
4 days0 dGREEN
Total Checks
7 (6 PASS, 1 OOS)0RED
Cpk (Fill Weight)
0.36-1.6GREEN
Quality Score
85/100-15RED
Parameter-Level Comparison
🔷 Compression Stage Parameters
ParameterSpecGolden AvgMET-0891 AvgΔ DiffRAG
Fill Weight490–510 mg501.5mg497.7mg-3.8mgAMBER
Hardness8–12 kP9.2kP9.13kP-0.07kPGREEN
Friability<1%0.6%0.55%-0.05%AMBER
Thickness7.9–8.3 mm8.1mm8.09mm-0.01mmGREEN
Disintegration<15 min12.3min12.19min-0.11minGREEN
🔶 Coating Stage Parameters
ParameterSpecGolden AvgMET-0891 AvgΔ DiffRAG
Weight Gain3–5%4.1%4.07%-0.03%GREEN
Pan Temp45–55 °C50°C49.86°C-0.14°CGREEN
🔵 Packing Stage Parameters · Blister
ParameterSpecGolden AvgMET-0891 AvgΔ DiffRAG
Tablet Count10 tabs10100GREEN
Seal IntegrityIntact100%100%0%GREEN
Print QualityLegible100%100%0%GREEN
Foil IntegrityNo damage100%100%0%GREEN
Fill Weight Distribution — MET-0891 vs Golden MET-0889

Compare value spread against spec window.

🟠 MET-0891 shows wider distribution (±7.2 mg) vs Golden (±0 mg). One or more readings fell outside spec (1 OOS event).

AI Quality Insights

Auto-generated analysis based on comparison to Golden Batch MET-0889.

OOS Event — Fill Weight Below Spec
RED

What: MET-0891 had 1 OOS event(s). Golden MET-0889 had zero OOS across all checks.

Why: Calibration drift on the compression machine likely caused compression force reduction between scheduled checks.

Action: ⚡ Tighten machine calibration interval and verify load cell zero before each batch.

Fill Weight Variation Higher Than Golden
AMBER

What: Std deviation: ±7.2 mg vs Golden ±0 mg. Wider distribution increases OOS risk.

Why: Less frequent in-process sampling allowed drift to accumulate between checks.

Action: ⚡ Increase compression check frequency to every 60 minutes.

Cpk (Fill Weight) Below Golden Standard
AMBER

What: MET-0891 Cpk: 0.36 vs Golden Cpk: 1.95.

Why: Correlated with higher variation. Equipment calibration and check frequency are likely contributors.

Action: ⚡ Monitor Cpk trend. If Cpk drops below 1.33, raise CAPA immediately.

Yield Matched or Improved vs Golden
GREEN

What: MET-0891 yield: 97.6% (1.1% vs Golden 96.5%).

Why: Improved raw material consistency or operator technique.

Action: ✅ Document this batch's practices for future reference.

Coating & Packing Matched Golden
GREEN

What: All Coating and Packing parameters within Golden envelope. Packing achieved 100/100.

Why: No changes to coating or packing equipment or procedures.

Action: ✅ Maintain current Coating and Packing practices.

🔷 Compression Stage
75/100
GOOD

Key issue: Fill Weight OOS

🔶 Coating Stage
100/100
EXCELLENT

All parameters within Golden envelope

🟢 Packing Stage
100/100
EXCELLENT

All checks PASS

Overall Batch Score
85/100
GOOD
Similarity to Golden
89%
Assessment
✅ RELEASED(threshold 70/100)
Bottleneck
Compression Stage (75/100) — focus here
Batch Ranking vs Golden — Metformin HCl 500mg Tablets (Last 6 Months)
RankBatch IDDate RangePass %OOSCycleScoreRAGAction
1MET-082931 Jan 2026 → 02 Feb 2026100%02 d100GREEN
2MET-083608 May 2026 → 10 May 2026100%02 d100GREEN
3MET-0889GOLDEN21 May 2026 → 24 May 2026100%04 d100GREENView
4MET-083016 Feb 2026 → 18 Feb 2026100%02 d97GREEN
5MET-083329 Mar 2026 → 31 Mar 2026100%02 d97GREEN
6MET-083525 Apr 2026 → 27 Apr 2026100%02 d97GREEN
7MET-089026 May 2026 → 29 May 2026100%04 d94GREEN
8MET-082509 Dec 2025 → 11 Dec 2025100%02 d94GREEN
9MET-082621 Dec 2025 → 23 Dec 2025100%02 d94GREEN
10MET-082706 Jan 2026 → 08 Jan 2026100%02 d94GREEN
11MET-082817 Jan 2026 → 19 Jan 2026100%02 d94GREEN
12MET-083127 Feb 2026 → 01 Mar 2026100%02 d94GREEN
Fleet Avg100%02.3 d96.3