Pharma CSV Pro - Professional Pharmaceutical Analysis
Enterprise-grade CSV analysis for pharmaceutical quality control, stability studies, and regulatory compliance.
Quick Start
CODEBLOCK0
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
CODEBLOCK1
Stability Study
CODEBLOCK2
QC Method Validation
CODEBLOCK3
Column Detection
Auto-detects pharmaceutical columns:
- -
batch, lot, batch_number → Batch/Lot identifiers - INLINECODE3 ,
potency, content → Assay results (%) - INLINECODE6 ,
related_substances, degradation → Impurity levels - INLINECODE9 ,
dt, disintegration → Dissolution (% or time) - INLINECODE12 ,
friability → Physical tests - INLINECODE14 ,
expiration_date, retest_date → Date tracking - INLINECODE17 ,
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 - INLINECODE21 : Human-readable summary
- INLINECODE22 : Multi-sheet workbook with charts
- INLINECODE23 : 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
技能名称: pharma-csv-pro
Pharma CSV Pro - 专业药物分析
面向制药质量控制、稳定性研究和法规合规的企业级CSV分析工具。
快速开始
bash
基础分析（含合规检查）
python3 scripts/pharma
analyzerpro.py data/batch_records.csv --compliance USP
稳定性研究（含趋势分析）
python3 scripts/pharma
analyzerpro.py data/stability.csv --study-type stability --trend-analysis
完整监管报告
python3 scripts/pharma
analyzerpro.py data/qc_data.csv --report-type regulatory --output report.pdf
功能特性
核心分析
- - 数据验证：模式验证、缺失数据检测、异常值识别
- 统计汇总：描述性统计、Cpk/Ppk计算、控制图
- 趋势分析：回归分析、漂移检测、保质期预测
法规合规
- - USP/EP/ChP标准：自动规格检查
- OOS/OOT检测：超标与超趋势标记
- 方法验证：准确度、精密度、线性、范围验证
报告生成
- - GMP合规报告：审计追踪、电子签名就绪
- 多格式输出：PDF、Excel、JSON、Markdown
- 可视化图表：控制图、趋势图、直方图
使用模式
批次记录分析
bash
python3 scripts/pharma
analyzerpro.py batch_records.csv \
--study-type batch \
--specs Assay:95.0-105.0,Impurity:<0.5 \
--detect-oos
稳定性研究
bash
python3 scripts/pharma
analyzerpro.py stability_24mo.csv \
--study-type stability \
--time-column Month \
--trend-analysis \
--shelf-life-prediction
QC方法验证
bash
python3 scripts/pharma
analyzerpro.py method_val.csv \
--study-type method-validation \
--parameters Accuracy,Precision,Linearity
列检测
自动识别药物相关列：
- - batch、lot、batchnumber → 批次/批号标识
- assay、potency、content → 含量测定结果（%）
- impurity、relatedsubstances、degradation → 杂质水平
- dissolution、dt、disintegration → 溶出度（%或时间）
- hardness、friability → 物理测试
- expiry、expirationdate、retestdate → 日期追踪
- storage_condition、temp、humidity → 稳定性条件
合规标准
USP（美国药典）
- - 含量限度：95.0% - 105.0%（典型值）
- 杂质阈值：依据USP <621>、<1086>
- 溶出度Q值（通常为75%或80%）
EP（欧洲药典）
- - 含量范围与EP各论一致
- 杂质报告阈值
- 溶出度接受标准
ChP（中国药典）
- - 含量规格依据ChP各论
- 中药（TCM）特定限度
- 微生物限度依据ChP <1105>、<1106>
输出格式
- - json：机器可读，含完整元数据
- markdown：人类可读摘要
- excel：多工作表工作簿（含图表）
- pdf：GMP合规格式化报告
高级选项
详见 references/advanced-usage.md：
- - 自定义规格文件
- LIMS系统集成
- 自动化流水线API使用
- 自定义报告模板
