Pharma Csv Pro

Professional pharmaceutical CSV analysis with regulatory compliance, OOS/OOT detection, stability trending, and GMP-compliant reporting. Use for batch record...

Security Scan

The skill's code and runtime instructions are coherent with its stated purpose (local CSV-based pharmaceutical QC/stability analysis); it does not request credentials, install software, or perform network activity by default.

Purpose & Capability

Name/description (pharmaceutical CSV analysis, OOS/OOT, regulatory reports) matches the included SKILL.md, example CSVs, and the Python script which implements validation, statistics, trend analysis and report generation. The examples and code only operate on user-provided CSV files.

Instruction Scope

SKILL.md instructs running the included script against local CSV files and documents optional LIMS integration examples. The runtime instructions and the script operate on file input only and do not instruct reading unrelated system files or environment variables. Note: the docs include an example showing how a user could post results to a LIMS API (requests.post) — that example is user-driven and not executed by the skill itself.

Install Mechanism

No install spec is present; this is an instruction-only skill with a bundled Python script. No downloads, package installs, or archive extraction occur as part of the skill.

Credentials

The skill requires no environment variables, credentials, or config paths. The code does not read environment secrets or network endpoints by default. The LIMS integration shown in references is a manual example that would require the user to supply their own API token and endpoint.

Persistence & Privilege

Skill does not request permanent presence (always: false). It contains no self-install or configuration changes to the agent or other skills. Autonomous invocation is allowed by platform default but this skill has no network/backchannel capability that would increase risk.

Assessment

This package appears to be a local CSV analysis tool and is internally consistent. Before using for regulated work, (1) validate outputs on known datasets and confirm the statistical methods meet your SOPs/regulatory expectations, (2) treat input CSVs as sensitive — they may contain regulated or personal data — and run the tool in an environment with appropriate access controls, (3) if you follow the LIMS integration examples, supply only trusted endpoints and tokens and review any integration code you add, and (4) review the script yourself or with your security/compliance team before using it in production or submitting reports to regulators.

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