Skill: teagec/pharma-csv-pro (version 1.0.0)

--- name: pharma-csv-pro description: 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. --- # Pharma CSV Pro - Professional Pharmaceutical Analysis Enterprise-grade CSV analysis for pharmaceutical quality control, stability studies, and regulatory compliance. ## Quick Start ```bash # 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 ```bash 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 ```bash python3 scripts/pharma_analyzer_pro.py stability_24mo.csv \ --study-type stability \ --time-column Month \ --trend-analysis \ --shelf-life-prediction ``` ### QC Method Validation ```bash 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


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