NABIX 500mg Film-Coated Tablets
Film-Coated Tablet Code: NBX-TAB-500
Parameter: Dissolution & Assay
Spec: 90.00 – 110.00 %
Target Cpk: 1.33
Yield Target: 97.50%
cGMP Process Controlled: 5 batch(es) evaluated. Process Cpk of 3.53 satisfies target requirement (1.33).
Total Batches
5
Manufactured & Released
Average Yield
98.22%
Target: ≥ 97.50%
FP Mean Assay
100.10%
Spec: 90.0–110.0%
Bulk Assay Mean
100.26%
In-Process Stage
Std Dev (σ)
0.935
% RSD: 0.93%
Process Cp
3.56
Potential Width
Process Cpk
3.53
Target: 1.33
OOS Batches
0
Out of Spec
Capability Calculation Engine
Exact Formula Breakdown
Cpk = min [(110.00 − 100.10) / (3 × 0.935), (100.10 − 90.00) / (3 × 0.935)] = min (3.53, 3.60) = 3.53
Cpk = min(Cpu, Cpl). Calculated from 5 valid Finished Product Assay observations.
Classification:
Excellent / Highly Robust (Six Sigma)
Operational Risk:
Negligible
Upper (Cpu) / Lower (Cpl):
3.53 / 3.60
Finished Product Assay Trend by Batch
Batch observed potency plotted against USL, LSL, Mean, and statistical ±3σ reference limits
Percentage Yield Trend
Batch yield percentage against mean yield target
Process Capability (Cpk vs Cpu vs Target)
Observed capability indices vs 1.33 target
🧪 pH Quality Overview & Batch Trend
Valid pH Readings: 0 •
Mean pH: — •
Std Dev: — •
Range: —
APQR Batch Manufacturing Stage Flow
End-to-end manufacturing stage verification cards with automatic Out-of-Specification detection
Batch:
TB 101
Mfg: 01-2025 | Exp: 12-2027
NORMAL
Mfg Month
01-2025
Batch Number
TB 101
Size / Packing
10x10 Blister
Volume (Batch Size)
250,000 Tabs
Expiry Date
12-2027
% Yield
98.20%
Batch Status
NORMAL
Finished Product Assay (Observed %)
99.50%
Bulk Assay (Observed %)
100.10%
Specification Review
WITHIN SPECIFICATION
Batch:
TB 102
Mfg: 03-2025 | Exp: 02-2028
NORMAL
Mfg Month
03-2025
Batch Number
TB 102
Size / Packing
10x10 Blister
Volume (Batch Size)
250,000 Tabs
Expiry Date
02-2028
% Yield
97.90%
Batch Status
NORMAL
Finished Product Assay (Observed %)
100.80%
Bulk Assay (Observed %)
100.40%
Specification Review
WITHIN SPECIFICATION
Batch:
TB 103
Mfg: 06-2025 | Exp: 05-2028
NORMAL
Mfg Month
06-2025
Batch Number
TB 103
Size / Packing
10x10 Blister
Volume (Batch Size)
250,000 Tabs
Expiry Date
05-2028
% Yield
98.40%
Batch Status
NORMAL
Finished Product Assay (Observed %)
98.90%
Bulk Assay (Observed %)
99.80%
Specification Review
WITHIN SPECIFICATION
Batch:
TB 104
Mfg: 09-2025 | Exp: 08-2028
NORMAL
Mfg Month
09-2025
Batch Number
TB 104
Size / Packing
10x10 Blister
Volume (Batch Size)
250,000 Tabs
Expiry Date
08-2028
% Yield
98.10%
Batch Status
NORMAL
Finished Product Assay (Observed %)
101.20%
Bulk Assay (Observed %)
100.70%
Specification Review
WITHIN SPECIFICATION
Batch:
TB 105
Mfg: 12-2025 | Exp: 11-2028
NORMAL
Mfg Month
12-2025
Batch Number
TB 105
Size / Packing
10x10 Blister
Volume (Batch Size)
250,000 Tabs
Expiry Date
11-2028
% Yield
98.50%
Batch Status
NORMAL
Finished Product Assay (Observed %)
100.10%
Bulk Assay (Observed %)
100.30%
Specification Review
WITHIN SPECIFICATION
Excel-Style Interactive Batch Data Entry
Click any cell to edit • Copy multiple cells from Excel and press Ctrl + V to paste • Real-time recalculation.
| # | Mfg Month |
Batch Number |
Size / Packing |
Volume (Batch Size) |
Expiry Date |
% Yield |
Status | Finished Product Assay (%) |
Bulk Assay (%) |
pH | Action |
|---|
Months Analysed
5
Normalized Time Periods
Highest FP Assay Month
09-2025 (101.2%)
Peak Finished Product Mean
Highest Bulk Month
09-2025 (100.7%)
Peak Bulk Formulation Mean
Largest Delta (Bulk − FP)
06-2025 (+0.9%)
Max Bulk vs FP Variance
Monthly FP Assay vs Bulk Assay Average
Monthly Average Percentage Yield
Monthly Manufacturing Aggregation & Delta Summary
| Mfg Month | Total Batches | Avg FP Assay | Avg Bulk Assay | Avg Yield % | Difference (Bulk − FP) |
|---|---|---|---|---|---|
| 01-2025 | 1 | 99.50% | 100.10% | 98.20% | +0.60% |
| 03-2025 | 1 | 100.80% | 100.40% | 97.90% | -0.40% |
| 06-2025 | 1 | 98.90% | 99.80% | 98.40% | +0.90% |
| 09-2025 | 1 | 101.20% | 100.70% | 98.10% | -0.50% |
| 12-2025 | 1 | 100.10% | 100.30% | 98.50% | +0.20% |
Out of Specification (OOS / OOT)
| Ref # | Batch | Observed Result | Status | Action |
|---|---|---|---|---|
| No OOS records logged. | ||||
Deviations & Non-Conformances
| Deviation # | Class | Description | Status | Action |
|---|---|---|---|---|
| No deviations logged. | ||||
Corrective & Preventive Actions (CAPA)
| CAPA # | Action Plan | Owner / Due | Status | Action |
|---|---|---|---|---|
| No CAPAs logged. | ||||
Ongoing Stability Studies
| Protocol | Condition | Time Point | Assay / pH | Action |
|---|---|---|---|---|
| No stability records logged. | ||||
Executive APQR Document Preview
Formatted 3-page A4 Landscape review ready for QA Sign-Off & GMP submission.
Quality Assurance • APQR Review
Annual Product Quality Review (APQR)
Product: NABIX 500mg Film-Coated Tablets • Parameter: Dissolution & Assay
Doc Ref: APQR-2026-NABI
Review Date: 03 Sep 2026
Spec: 90.00 – 110.00 %
Batches
5
FP Mean
100.10%
Yield Mean
98.22%
Std Dev (σ)
0.935
Process Cpk
3.53
Process Cp
3.56
OOS
0
Statistical Capability Details:
Cpk = min [(110.00 − 100.10) / (3 × 0.935), (100.10 − 90.00) / (3 × 0.935)] = min (3.53, 3.60) = 3.53
Observed Range: 98.90% to 101.20% • RSD: 0.93%
Six Sigma Status
Excellent / Highly Robust (Six Sigma)
Target Cpk: 1.33 | Risk: Negligible
APQR Conclusion: The manufacturing campaign for NABIX 500mg Film-Coated Tablets was reviewed under approved QA procedures.
All reviewed batches conformed to Finished Product Assay specifications (90.0% to 110.0%). Process capability index Cpk of 3.53 satisfies cGMP control criteria.
Prepared by:
QA Executive / Officer
Signature & Date
Reviewed by:
Production / QC Head
Signature & Date
Approved by:
Head of Quality Assurance
Signature & Date
GMP Audit Trail & Record Change Log
| Timestamp | User | Action | Details | IP |
|---|---|---|---|---|
| 2026-09-03 06:37:52 | QA Officer | INITIALIZED_SYSTEM | NABIX APQR Decision Platform initialized with validated product specifications and historical campaigns. | 127.0.0.1 |