SkillHub

pharma-csv-pro

v1.0.0

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.

Sourced from ClawHub, Authored by teagec

Installation

Please help me install the skill `pharma-csv-pro` from SkillHub official store. npx skills add teagec/pharma-csv-pro

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