pharma-csv-pro（pharma CSV 专业版）

Pharma CSV Pro - Professional Pharmaceutical Analysis

Enterprise-grade CSV analysis for pharmaceutical quality control, stability studies, and regulatory compliance.

Quick Start

# Basic analysis with compliance check
python3 scripts/pharma_analyzer_pro.py data/batch_records.csv --compliance USP

# Stability study with trend analysis
python3 scripts/pharma_analyzer_pro.py data/stability.csv --study-type stability --trend-analysis

# Full regulatory report
python3 scripts/pharma_analyzer_pro.py data/qc_data.csv --report-type regulatory --output report.pdf

Features

Core Analysis

• Data Validation: Schema validation, missing data detection, outlier identification
• Statistical Summary: Descriptive stats, Cpk/Ppk calculations, control charts
• Trend Analysis: Regression, drift detection, shelf-life prediction

Regulatory Compliance

• USP/EP/ChP Standards: Automated specification checking
• OOS/OOT Detection: Out-of-specification and out-of-trend flagging
• Method Validation: Accuracy, precision, linearity, range verification

Reporting

• GMP-Compliant Reports: Audit trail, electronic signatures ready
• Multiple Formats: PDF, Excel, JSON, Markdown
• Visualization: Control charts, trend plots, histograms

Usage Patterns

Batch Record Analysis

python3 scripts/pharma_analyzer_pro.py batch_records.csv \
  --study-type batch \
  --specs "Assay:95.0-105.0,Impurity:<0.5" \
  --detect-oos

Stability Study

python3 scripts/pharma_analyzer_pro.py stability_24mo.csv \
  --study-type stability \
  --time-column Month \
  --trend-analysis \
  --shelf-life-prediction

QC Method Validation

python3 scripts/pharma_analyzer_pro.py method_val.csv \
  --study-type method-validation \
  --parameters "Accuracy,Precision,Linearity"

Column Detection

Auto-detects pharmaceutical columns:

• batch, lot, batch_number → Batch/Lot identifiers
• assay, potency, content → Assay results (%)
• impurity, related_substances, degradation → Impurity levels
• dissolution, dt, disintegration → Dissolution (% or time)
• hardness, friability → Physical tests
• expiry, expiration_date, retest_date → Date tracking
• storage_condition, temp, humidity → Stability conditions

Compliance Standards

USP (United States Pharmacopeia)

• Assay limits: 95.0% - 105.0% (typical)
• Impurity thresholds per USP <621>, <1086>
• Dissolution Q-value (typically 75% or 80%)

EP (European Pharmacopoeia)

• Similar assay ranges with EP-specific monographs
• Impurity reporting thresholds
• Dissolution acceptance criteria

ChP (Chinese Pharmacopoeia)

• Assay specifications per ChP monographs
• Traditional Chinese Medicine (TCM) specific limits
• Microbial limits per ChP <1105>, <1106>

Output Formats

• json: Machine-readable with full metadata
• markdown: Human-readable summary
• excel: Multi-sheet workbook with charts
• pdf: GMP-compliant formatted report

Advanced Options

See references/advanced-usage.md for:

• Custom specification files
• Integration with LIMS systems
• API usage for automated pipelines
• Custom report templates