pharmasee-cmc-workbench

name

pharmasee-cmc-workbench

description

Unified CMC workbench for Chinese pharmaceutical companies. Orchestrates three modules: CMC Forge (execution), CMC Research (knowledge), and Scientific Writer (writing quality). Triggers when the user asks about any integrated CMC workflow that spans multiple modules, such as: China-first then global CMC roadmap, inbound localization gap assessment, Module 3 authoring with writing quality review, tech transfer + comparability strategy, FDA/EMA-facing English CMC summary audit, or any request that explicitly mentions "PharmaSee", "CMC workbench", "integrated CMC", or asks for a multi-step CMC workflow that goes beyond a single module's scope. Also triggers when the user's request clearly requires knowledge lookup + CMC execution + writing quality, or when the user asks for a workflow rather than a single task. Do NOT trigger for requests that fall cleanly within a single module's scope — route those to CMC Forge, CMC Research, or Scientific Writer directly.

PharmaSee CMC Workbench

A unified AI-assisted CMC workbench integrating three specialized modules for Chinese pharmaceutical CMC work — from CDE/NMPA filings through global FDA/EMA readiness.

Module Architecture

pharmasee-cmc-workbench/
├── SKILL.md                          ← You are here
├── README.md                         Quick-start guide
├── WORKBENCH.md                      Architecture & design decisions
├── routing.md                        Signal-to-module routing (8 routes)
│
├── skills/
│   ├── cmc-forge/                    Execution engine (DRAFT/ASSESS/PLAN/TRAIN)
│   └── scientific-writer/            Writing quality (WRITE/REVIEW/DIAGNOSE/LEARN)
│
├── knowledge/
│   └── CMC_Research/                 Knowledge base (18 sub-documents + resources)
│
├── workflows/                        5 integrated workflows
├── examples/                         5 integrated scenario examples
└── evals/                            8 cross-module evaluation scenarios

Core Principle: Module Orchestration

This skill does NOT replace its three modules. It orchestrates them:

Module	Role	When Active
CMC Research	Knowledge layer	Regulatory lookup, case reference, template retrieval
CMC Forge	Execution layer	Drafting, assessing, planning CMC deliverables
Scientific Writer	Quality layer	Writing quality audit, language polish, structural diagnosis

Integration Patterns

Pattern A: Knowledge-Grounded Assessment

CMC Research → CMC Forge

Look up regulatory requirements, then assess project readiness.

Pattern B: Draft-then-Review

CMC Forge → Scientific Writer

Generate CMC draft, then apply 5-pass writing quality audit.

Pattern C: Full Pipeline

CMC Research → CMC Forge → Scientific Writer

Knowledge lookup → CMC deliverable → Writing quality polish.

Pattern D: Standalone Module

Any module operates independently for requests within its scope.

Routing Logic

When a request arrives, match against these rules (priority order):

1. Single-module request → Route to the appropriate module directly. Do NOT activate the workbench orchestrator.

   • CMC drafting/assessment/planning/training → skills/cmc-forge/SKILL.md
   • Scientific writing/review/diagnosis → skills/scientific-writer/SKILL.md
   • Regulatory knowledge lookup → knowledge/CMC_Research/ (read relevant sub-document)

2. Multi-module request → Activate this workbench skill. Choose the appropriate workflow:

User Signal	Workflow	Modules
Readiness assessment, gap analysis, IND readiness	workflows/01-cmc-readiness-assessment.md	CMC Research → CMC Forge (ASSESS)
Module 3 drafting, CTD authoring	workflows/02-module3-authoring.md	CMC Research → CMC Forge (DRAFT+PLAN) → Scientific Writer
China → global strategy, cross-regional roadmap	workflows/03-china-global-roadmap.md	CMC Research → CMC Forge (ASSESS+PLAN)
Tech transfer, comparability, site change	workflows/04-tech-transfer-comparability.md	CMC Research → CMC Forge (DRAFT+ASSESS)
Writing quality review, English audit	workflows/05-writing-quality-review.md	CMC Forge → Scientific Writer (REVIEW)

3. Ambiguous request → Default to the routing rules in routing.md. If still unclear, ask the user to clarify scope.

Operational Procedure

When the workbench is activated:

Step 1: Classify the Request

• Determine which modules are needed
• Select the matching workflow from workflows/
• If no workflow matches, use the routing rules in routing.md

Step 2: Load Minimum Required Files

• Only load the reference files specified in the workflow
• Do NOT load all module files simultaneously
• Each workflow specifies the minimum required files

Step 3: Execute the Workflow

• Follow the workflow's step-by-step process
• Hand off between modules at defined points
• Maintain context across module transitions

Step 4: Apply Quality Gates

• All outputs carry: ⚠️ DRAFT — For controlled review. Not a GMP-controlled document.
• Include classification level (L1–L4)
• Specify required human reviewers

Step 5: Deliver

• Present output in the workflow's specified structure
• Include all compliance markers
• List assumptions and unknowns

Hard Boundaries

This workbench MUST NOT:

1. Fabricate data — No invented batch data, specifications, validation results, stability data, or regulatory conclusions
2. Replace human authority — All outputs require QA/QP/RA/SME review and approval
3. Make final regulatory classifications — Change classifications (Minor/Major/Critical) are advisory only
4. Authorize GMP actions — No batch release, deviation closure, or change implementation
5. Generate final submission documents — All outputs are drafts for controlled review

Regulatory Currency Boundary

The bundled CMC Research materials are a local knowledge snapshot, not a live regulatory database. For any current filing strategy, compliance decision, or health-authority response, verify requirements against official NMPA/CDE, ICH, FDA, EMA, and pharmacopoeial sources before relying on the output.

Company Posture Framework

From skills/cmc-forge/references/china-global-cmc-operating-model.md, identify the user's posture:

Posture	Description
China-only	Domestic market focus
China-first then global	Start in China, expand outward
Global-first with China bridge	Global product, adding China
Inbound localization	Overseas product → China manufacturing
Outbound licensing	China product → global partner

Apply the posture when routing China/global CMC requests.

Bilingual Terminology

When working across Chinese and English CMC contexts:

• Use consistent bilingual terms (see skills/cmc-forge/CMC_FORGE_PROJECT_NOTE.md)
• Maintain terminology consistency (Banana Rule) within each output language
• Chinese regulatory terms reference CMC Research sources
• English regulatory terms follow ICH/FDA conventions

First Move

When the workbench is activated, collect context before executing:

Required context (if not provided):
1. Drug type (mAb, BsAb, ADC, CGT, small molecule, etc.)
2. Development stage (pre-IND, Phase I/II/III, BLA, post-approval)
3. Target region(s) (China, US, EU, multi-regional)
4. Company posture (China-only, China-first then global, etc.)
5. Specific task or question

If context is partially missing, proceed with reasonable defaults and state assumptions explicitly.

Reference File Index

CMC Forge (skills/cmc-forge/)

• SKILL.md — Skill definition and trigger rules
• references/routing.md — Internal 5-route routing
• references/project-archetypes.md — 7 best-fit project types
• references/deliverable-patterns.md — 6 reusable output patterns
• references/china-global-cmc-operating-model.md — China/global strategy
• references/gxp-boundaries.md — Safe-use boundaries
• references/quality-checklist.md — 42-point quality checklist
• references/regulatory-anchors.md — ICH/FDA/NMPA guidance links
• templates/ — 5 document scaffolds (PPQ, Module 3, stage-gate, tech transfer, change-comparability)
• playbooks/ — 6 domain scripts (developability, risk-comparability, compliance-continuum, GMP/QA, early-prioritization, content-structuring)
• examples/ — 2 worked mock outputs
• evals/evals.json — 10 single-module evaluation scenarios

Scientific Writer (skills/scientific-writer/)

• SKILL.md — Skill definition and trigger rules
• references/section-models.md — Consolidated section models + language tables
• references/writing-quality.md — Grammar, self-editing, common errors
• extracted-models/ — private extraction notes; exclude from public release packages

CMC Research (knowledge/CMC_Research/)

• CMC_COMPREHENSIVE_GUIDE/ — 18 sub-documents (42+ sections)
• resources/zh-CN/ — Case studies, templates, regulation links
• COMPLIANCE_FRAMEWORK.md — Compliance assurance framework
• SUMMARY.md — Navigation table of contents

Workflow references such as declaration_practice/ind_cmc_zh.md are relative to knowledge/CMC_Research/CMC_COMPREHENSIVE_GUIDE/ unless another base path is specified.

Conflict Resolution

When CMC Forge and CMC Research provide conflicting information:

• CMC Research is authoritative for regulatory facts and requirements
• CMC Forge provides frameworks and templates for structuring work
• When in doubt, cite both and flag for human review

When Scientific Writer suggestions conflict with CMC regulatory terminology:

• Regulatory terminology is preserved — do not "improve" standard terms
• Language quality improvements apply to sentence structure and clarity, not domain vocabulary