AI Quality Control Report

Comprehensive batch analysis with AI-powered insights

PharmaCare Solutions Ltd. Quality Control Manager
94
Overall QC Score
15/15
Tests Passed
1
Tests for Review
0
Tests Failed
AI Risk Assessment
AI Confidence: 92%
31
Risk Score
LOW RISK
Within acceptable limits
Top AI Insights:
  • All critical parameters within specification
  • Minor temperature excursion detected
  • Excellent stability profile predicted
  • High confidence in authenticity (98%)
Risk Factors Identified:
Temperature (Low)
Dissolution (Medium)
Potency (Very Low)
Test Results Summary
Test Parameter Result Specification Status Trend AI Confidence
Assay (Potency) 98.7% 95.0-105.0% PASS +0.3%
96%
Dissolution (30 min) 89% ≥85% PASS Stable
82%
Related Substances 0.3% ≤0.5% PASS -0.1%
94%
Residual Solvents 0.02% ≤0.05% PASS Stable
98%
Microbial Limits Within limits USP <61> REVIEW +1 CFU
75%
Uniformity of Weight ±2.1% ±5.0% PASS +0.5%
92%
Stability Analysis
Accelerated Stability Study
Predicted Shelf Life
30 months
Predicted beyond labeled expiry
Labeled: 24 months Predicted: 30 months
AI Prediction: Shelf life extension possible based on current data
QC Decision

APPROVED

Batch meets all quality specifications

Reviewed By: Dr. Priya Sharma
Date: 2024-03-15
Time: 14:30 IST
Signature:
Comparative Analysis
vs Previous Batch (AMX-2024-089):
Assay Potency +0.5%
Dissolution -1.2%
Impurities -0.05%
Export Options
Include in Export:
Detailed Parameter Analysis
Assay Potency
98.7%
Within specification
+0.3%
vs target
95% 105%
Dissolution Profile
89%
At specification limit
+4%
above minimum
85% 100%
Related Substances
0.3%
Well within limit
-0.2%
below limit
0% 0.5%
Temperature Excursion Analysis
Manufacturing Consistency
Regulatory Compliance Summary
FDA 21 CFR

Fully compliant

EU GMP

Fully compliant

WHO Guidelines

Fully compliant

Compliance Notes:
All regulatory requirements met. This batch is ready for regulatory submission.
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