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This skill may not reflect the latest upstream change

Federal Register Rules update on 2026-06-29 may affect this skill Last checked 6/27/2026.

pharma-quality-control

Audit pharmaceutical QC laboratory operations -- OOS/OOT investigations, stability program trending, analytical method validation status, release testing optimization, and specification compliance. Covers ICH Q1A-Q1E stability guidelines, ICH Q2(R2) method validation, USP compendial verification, ALCOA+ data integrity, Croston shelf life estimation, and LIMS/CDS system evaluation. Use when reviewing OOS investigation quality, trending stability data, auditing method validation coverage, optimizing release testing turnaround, or assessing data integrity in QC labs.

v2.0.0New
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Install this skill

Run this command in your terminal. No account required — it auto-detects your AI tool and installs the skill file.

npx @skills-hub-ai/cli install pharma-quality-control
Or download directly:
Browse all CLI commands →

Setup by platform

Claude Code

~/.claude/skills/<skill>/SKILL.md

Setup guide →

Install

One-click setup for your editor

Run in your project root

npx @skills-hub-ai/cli install pharma-quality-control --target claude-code

Instructions

This skill doesn’t include stateful context yet, instructions only. Learn about stateful skills.

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Frequently asked questions about pharma-quality-control

What does the pharma-quality-control skill do?

Audit pharmaceutical QC laboratory operations -- OOS/OOT investigations, stability program trending, analytical method validation status, release testing optimization, and specification compliance. Covers ICH Q1A-Q1E stability guidelines, ICH Q2(R2) method validation, USP compendial verification, ALCOA+ data integrity, Croston shelf life estimation, and LIMS/CDS system evaluation. Use when reviewing OOS investigation quality, trending stability data, auditing method validation coverage, optimizing release testing turnaround, or assessing data integrity in QC labs. It's a reusable SKILL.md instruction set that loads into your AI coding assistant on demand, no prompt engineering, no copy-pasting every session.

How do I install the pharma-quality-control skill?

Run `npx @skills-hub-ai/cli install pharma-quality-control` from your terminal. The CLI writes the SKILL.md to the correct location for your AI tool (e.g. ~/.claude/skills/pharma-quality-control/ for Claude Code or ~/.cursor/skills/ for Cursor with --target cursor) and adds it to your project's .skills.json lockfile.

Which AI tools does pharma-quality-control work with?

pharma-quality-control runs in Claude Code. It follows the open Agent Skills standard (SKILL.md), so the same skill works in every supported tool without modification.

Is the pharma-quality-control skill free?

Yes. Every skill on skills-hub.ai is free and open-source. There are no premium tiers, paywalls, or usage limits. You only pay for whatever AI assistant you're already using.

How do I use pharma-quality-control after installing it?

In Claude Code, type `/pharma-quality-control` (or whatever slash command the skill registers) and the AI follows the skill's instructions immediately. You can also reference it by name in natural language, your AI loads the skill into context when relevant.

Can I share the pharma-quality-control skill with my team?

Yes. Commit your project's .skills.json lockfile and teammates run `npx @skills-hub-ai/cli install` (no args) to install every skill at the exact version you pinned. Organization-scoped installs work via skills-hub.ai organizations.