NABIX 10mg/ml Injection
Sterile Injectable Solution Code: NBX-INJ-010
Parameter: Finished Product Assay
Spec: 95.00 – 105.00 %
Target Cpk: 1.33
Yield Target: 98.00%
pH: 6.80 – 7.60
cGMP Process Controlled: 12 batch(es) evaluated. Process Cpk of 1.54 satisfies target requirement (1.33).
Total Batches
12
Manufactured & Released
Average Yield
99.17%
Target: ≥ 98.00%
FP Mean Assay
99.94%
Spec: 95.0–105.0%
Bulk Assay Mean
100.30%
In-Process Stage
Std Dev (σ)
1.066
% RSD: 1.07%
Process Cp
1.56
Potential Width
Process Cpk
1.54
Target: 1.33
OOS Batches
0
Out of Spec
Capability Calculation Engine
Exact Formula Breakdown
Cpk = min [(105.00 − 99.94) / (3 × 1.066), (99.94 − 95.00) / (3 × 1.066)] = min (1.58, 1.54) = 1.54
Cpk = min(Cpu, Cpl). Calculated from 12 valid Finished Product Assay observations.
Classification:
Good / Capable
Operational Risk:
Low
Upper (Cpu) / Lower (Cpl):
1.58 / 1.54
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: 12 •
Mean pH: 7.20 •
Std Dev: 0.027 •
Range: 7.15 – 7.24
APQR Batch Manufacturing Stage Flow
End-to-end manufacturing stage verification cards with automatic Out-of-Specification detection
Batch:
VM 198
Mfg: 02-2025 | Exp: 01-2027
NORMAL
Mfg Month
02-2025
Batch Number
VM 198
Size / Packing
10 ml Vial
Volume (Batch Size)
400 Litre
Expiry Date
01-2027
% Yield
99.60%
Batch Status
NORMAL
Finished Product Assay (Observed %)
97.90%
Bulk Assay (Observed %)
100.29%
Specification Review
WITHIN SPECIFICATION
Batch:
VM 396
Mfg: 03-2025 | Exp: 02-2027
NORMAL
Mfg Month
03-2025
Batch Number
VM 396
Size / Packing
10 ml Vial
Volume (Batch Size)
400 Litre
Expiry Date
02-2027
% Yield
99.88%
Batch Status
NORMAL
Finished Product Assay (Observed %)
98.40%
Bulk Assay (Observed %)
100.15%
Specification Review
WITHIN SPECIFICATION
Batch:
VM 421
Mfg: 04-2025 | Exp: 03-2027
NORMAL
Mfg Month
04-2025
Batch Number
VM 421
Size / Packing
10 ml Vial
Volume (Batch Size)
400 Litre
Expiry Date
03-2027
% Yield
98.90%
Batch Status
NORMAL
Finished Product Assay (Observed %)
99.10%
Bulk Assay (Observed %)
100.05%
Specification Review
WITHIN SPECIFICATION
Batch:
VM 455
Mfg: 05-2025 | Exp: 04-2027
NORMAL
Mfg Month
05-2025
Batch Number
VM 455
Size / Packing
10 ml Vial
Volume (Batch Size)
400 Litre
Expiry Date
04-2027
% Yield
99.20%
Batch Status
NORMAL
Finished Product Assay (Observed %)
100.20%
Bulk Assay (Observed %)
100.31%
Specification Review
WITHIN SPECIFICATION
Batch:
VM 488
Mfg: 06-2025 | Exp: 05-2027
NORMAL
Mfg Month
06-2025
Batch Number
VM 488
Size / Packing
10 ml Vial
Volume (Batch Size)
400 Litre
Expiry Date
05-2027
% Yield
98.70%
Batch Status
NORMAL
Finished Product Assay (Observed %)
101.10%
Bulk Assay (Observed %)
100.20%
Specification Review
WITHIN SPECIFICATION
Batch:
VM 512
Mfg: 07-2025 | Exp: 06-2027
NORMAL
Mfg Month
07-2025
Batch Number
VM 512
Size / Packing
10 ml Vial
Volume (Batch Size)
400 Litre
Expiry Date
06-2027
% Yield
99.40%
Batch Status
NORMAL
Finished Product Assay (Observed %)
100.50%
Bulk Assay (Observed %)
100.45%
Specification Review
WITHIN SPECIFICATION
Batch:
VM 544
Mfg: 08-2025 | Exp: 07-2027
NORMAL
Mfg Month
08-2025
Batch Number
VM 544
Size / Packing
10 ml Vial
Volume (Batch Size)
400 Litre
Expiry Date
07-2027
% Yield
99.15%
Batch Status
NORMAL
Finished Product Assay (Observed %)
99.80%
Bulk Assay (Observed %)
100.10%
Specification Review
WITHIN SPECIFICATION
Batch:
VM 579
Mfg: 09-2025 | Exp: 08-2027
NORMAL
Mfg Month
09-2025
Batch Number
VM 579
Size / Packing
10 ml Vial
Volume (Batch Size)
400 Litre
Expiry Date
08-2027
% Yield
98.60%
Batch Status
NORMAL
Finished Product Assay (Observed %)
100.90%
Bulk Assay (Observed %)
100.60%
Specification Review
WITHIN SPECIFICATION
Batch:
VM 602
Mfg: 10-2025 | Exp: 09-2027
NORMAL
Mfg Month
10-2025
Batch Number
VM 602
Size / Packing
10 ml Vial
Volume (Batch Size)
400 Litre
Expiry Date
09-2027
% Yield
99.50%
Batch Status
NORMAL
Finished Product Assay (Observed %)
101.30%
Bulk Assay (Observed %)
100.80%
Specification Review
WITHIN SPECIFICATION
Batch:
VM 638
Mfg: 11-2025 | Exp: 10-2027
NORMAL
Mfg Month
11-2025
Batch Number
VM 638
Size / Packing
10 ml Vial
Volume (Batch Size)
400 Litre
Expiry Date
10-2027
% Yield
99.00%
Batch Status
NORMAL
Finished Product Assay (Observed %)
99.40%
Bulk Assay (Observed %)
99.95%
Specification Review
WITHIN SPECIFICATION
Batch:
VM 670
Mfg: 12-2025 | Exp: 11-2027
NORMAL
Mfg Month
12-2025
Batch Number
VM 670
Size / Packing
10 ml Vial
Volume (Batch Size)
400 Litre
Expiry Date
11-2027
% Yield
98.80%
Batch Status
NORMAL
Finished Product Assay (Observed %)
100.10%
Bulk Assay (Observed %)
100.25%
Specification Review
WITHIN SPECIFICATION
Batch:
VM 705
Mfg: 01-2026 | Exp: 12-2027
NORMAL
Mfg Month
01-2026
Batch Number
VM 705
Size / Packing
10 ml Vial
Volume (Batch Size)
400 Litre
Expiry Date
12-2027
% Yield
99.30%
Batch Status
NORMAL
Finished Product Assay (Observed %)
100.60%
Bulk Assay (Observed %)
100.40%
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
12
Normalized Time Periods
Highest FP Assay Month
10-2025 (101.3%)
Peak Finished Product Mean
Highest Bulk Month
10-2025 (100.8%)
Peak Bulk Formulation Mean
Largest Delta (Bulk − FP)
02-2025 (+2.39%)
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) |
|---|---|---|---|---|---|
| 02-2025 | 1 | 97.90% | 100.29% | 99.60% | +2.39% |
| 03-2025 | 1 | 98.40% | 100.15% | 99.88% | +1.75% |
| 04-2025 | 1 | 99.10% | 100.05% | 98.90% | +0.95% |
| 05-2025 | 1 | 100.20% | 100.31% | 99.20% | +0.11% |
| 06-2025 | 1 | 101.10% | 100.20% | 98.70% | -0.90% |
| 07-2025 | 1 | 100.50% | 100.45% | 99.40% | -0.05% |
| 08-2025 | 1 | 99.80% | 100.10% | 99.15% | +0.30% |
| 09-2025 | 1 | 100.90% | 100.60% | 98.60% | -0.30% |
| 10-2025 | 1 | 101.30% | 100.80% | 99.50% | -0.50% |
| 11-2025 | 1 | 99.40% | 99.95% | 99.00% | +0.55% |
| 12-2025 | 1 | 100.10% | 100.25% | 98.80% | +0.15% |
| 01-2026 | 1 | 100.60% | 100.40% | 99.30% | -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 |
|---|---|---|---|---|
| DEV-2025-042 | MINOR | Temporary autoclave sterilization cycle... | CLOSED | |
| DEV-2025-089 | MAJOR | Peristaltic filling line nozzle pressure... | CLOSED |
Corrective & Preventive Actions (CAPA)
| CAPA # | Action Plan | Owner / Due | Status | Action |
|---|---|---|---|---|
| CAPA-2025-019 | Updated standard preventive maintenance... | Engineering Lead / QA Officer 03 Oct 2026 |
CLOSED |
Ongoing Stability Studies
| Protocol | Condition | Time Point | Assay / pH | Action |
|---|---|---|---|---|
| STAB-NBX-2025-01 | 25°C / 60% RH | 0M | Assay: 100.50% | pH: 7.20 | |
| STAB-NBX-2025-01 | 25°C / 60% RH | 3M | Assay: 100.30% | pH: 7.19 | |
| STAB-NBX-2025-01 | 25°C / 60% RH | 6M | Assay: 100.10% | pH: 7.18 | |
| STAB-NBX-2025-01 | 25°C / 60% RH | 12M | Assay: 99.80% | pH: 7.16 | |
| STAB-NBX-2025-ACC | 40°C / 75% RH (Accelerated) | 6M | Assay: 98.90% | pH: 7.14 |
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 10mg/ml Injection • Parameter: Finished Product Assay
Doc Ref: APQR-2026-NABI
Review Date: 03 Sep 2026
Spec: 95.00 – 105.00 %
Batches
12
FP Mean
99.94%
Yield Mean
99.17%
Std Dev (σ)
1.066
Process Cpk
1.54
Process Cp
1.56
OOS
0
Statistical Capability Details:
Cpk = min [(105.00 − 99.94) / (3 × 1.066), (99.94 − 95.00) / (3 × 1.066)] = min (1.58, 1.54) = 1.54
Observed Range: 97.90% to 101.30% • RSD: 1.07%
Six Sigma Status
Good / Capable
Target Cpk: 1.33 | Risk: Low
APQR Conclusion: The manufacturing campaign for NABIX 10mg/ml Injection was reviewed under approved QA procedures.
All reviewed batches conformed to Finished Product Assay specifications (95.0% to 105.0%). Process capability index Cpk of 1.54 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 |