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 identifiersassay, potency, content → Assay results (%)impurity, related_substances, degradation → Impurity levelsdissolution, dt, disintegration → Dissolution (% or time)hardness, friability → Physical testsexpiry, expiration_date, retest_date → Date trackingstorage_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 metadatamarkdown: Human-readable summaryexcel: Multi-sheet workbook with chartspdf: 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
1---2name: pharma-csv-pro3description: Professional pharmaceutical CSV analysis with regulatory compliance, OOS/OOT detection, stability trending, and GMP-compliant reporting. Use for batch records analysis, stability studies, QC data validation, method validation, and regulatory submissions requiring USP/EP/ChP standard checks.4---56# Pharma CSV Pro - Professional Pharmaceutical Analysis78Enterprise-grade CSV analysis for pharmaceutical quality control, stability studies, and regulatory compliance.910## Quick Start1112```bash13# Basic analysis with compliance check14python3 scripts/pharma_analyzer_pro.py data/batch_records.csv --compliance USP1516# Stability study with trend analysis17python3 scripts/pharma_analyzer_pro.py data/stability.csv --study-type stability --trend-analysis1819# Full regulatory report20python3 scripts/pharma_analyzer_pro.py data/qc_data.csv --report-type regulatory --output report.pdf21```2223## Features2425### Core Analysis26- **Data Validation**: Schema validation, missing data detection, outlier identification27- **Statistical Summary**: Descriptive stats, Cpk/Ppk calculations, control charts28- **Trend Analysis**: Regression, drift detection, shelf-life prediction2930### Regulatory Compliance31- **USP/EP/ChP Standards**: Automated specification checking32- **OOS/OOT Detection**: Out-of-specification and out-of-trend flagging33- **Method Validation**: Accuracy, precision, linearity, range verification3435### Reporting36- **GMP-Compliant Reports**: Audit trail, electronic signatures ready37- **Multiple Formats**: PDF, Excel, JSON, Markdown38- **Visualization**: Control charts, trend plots, histograms3940## Usage Patterns4142### Batch Record Analysis43```bash44python3 scripts/pharma_analyzer_pro.py batch_records.csv \45 --study-type batch \46 --specs "Assay:95.0-105.0,Impurity:<0.5" \47 --detect-oos48```4950### Stability Study51```bash52python3 scripts/pharma_analyzer_pro.py stability_24mo.csv \53 --study-type stability \54 --time-column Month \55 --trend-analysis \56 --shelf-life-prediction57```5859### QC Method Validation60```bash61python3 scripts/pharma_analyzer_pro.py method_val.csv \62 --study-type method-validation \63 --parameters "Accuracy,Precision,Linearity"64```6566## Column Detection6768Auto-detects pharmaceutical columns:69- `batch`, `lot`, `batch_number` → Batch/Lot identifiers70- `assay`, `potency`, `content` → Assay results (%)71- `impurity`, `related_substances`, `degradation` → Impurity levels72- `dissolution`, `dt`, `disintegration` → Dissolution (% or time)73- `hardness`, `friability` → Physical tests74- `expiry`, `expiration_date`, `retest_date` → Date tracking75- `storage_condition`, `temp`, `humidity` → Stability conditions7677## Compliance Standards7879### USP (United States Pharmacopeia)80- Assay limits: 95.0% - 105.0% (typical)81- Impurity thresholds per USP <621>, <1086>82- Dissolution Q-value (typically 75% or 80%)8384### EP (European Pharmacopoeia)85- Similar assay ranges with EP-specific monographs86- Impurity reporting thresholds87- Dissolution acceptance criteria8889### ChP (Chinese Pharmacopoeia)90- Assay specifications per ChP monographs91- Traditional Chinese Medicine (TCM) specific limits92- Microbial limits per ChP <1105>, <1106>9394## Output Formats9596- `json`: Machine-readable with full metadata97- `markdown`: Human-readable summary98- `excel`: Multi-sheet workbook with charts99- `pdf`: GMP-compliant formatted report100101## Advanced Options102103See `references/advanced-usage.md` for:104- Custom specification files105- Integration with LIMS systems106- API usage for automated pipelines107- Custom report templates
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