342 lines
16 KiB
Python
342 lines
16 KiB
Python
"""Phase 1 project initialization and framework generation."""
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from __future__ import annotations
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import hashlib
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import re
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from datetime import datetime, timezone
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from pathlib import Path
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from typing import Any
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from scripts.runtime.artifacts import PROJECTS_DIR, ensure_phase_dirs, load_manifest, write_manifest
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from scripts.runtime.materials import ingest_input_materials, render_material_inventory
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from scripts.runtime.methods import ResearchMethod, ResearchMethodRegistry
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def utc_now_iso() -> str:
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return datetime.now(timezone.utc).replace(microsecond=0).isoformat()
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def slugify_topic(topic: str) -> str:
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slug = re.sub(r"[^a-zA-Z0-9]+", "-", topic.lower()).strip("-")
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if slug:
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return slug[:80]
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digest = hashlib.sha1(topic.encode("utf-8")).hexdigest()[:8]
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return f"research-{digest}"
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def create_project(
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*,
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topic: str,
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slug: str | None = None,
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projects_dir: Path = PROJECTS_DIR,
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method_key: str | None = None,
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report_type: str = "research",
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model_profile: str = "medium",
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target_words: int = 30000,
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input_materials: list[str] | None = None,
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) -> Path:
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method = ResearchMethodRegistry().get(method_key)
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project_slug = slug or slugify_topic(topic)
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project_root = projects_dir / project_slug
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if project_root.exists():
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raise FileExistsError(f"project already exists: {project_root}")
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ensure_phase_dirs(project_root)
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(project_root / "phase0" / "inputs").mkdir(parents=True, exist_ok=True)
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(project_root / "phase0" / "extracted").mkdir(parents=True, exist_ok=True)
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material_inventory = ingest_input_materials(project_root, input_materials)
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now = utc_now_iso()
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manifest: dict[str, Any] = {
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"version": "0.20.0",
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"runtime": "python-core-v0.20",
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"topic": topic,
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"slug": project_slug,
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"report_title": topic,
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"type": report_type,
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"work_language": "zh",
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"model_profile": model_profile,
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"research_method": method.key,
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"target_words": target_words,
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"input_materials": input_materials or [],
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"material_inventory": material_inventory,
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"created_at": now,
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"updated_at": now,
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"phase1": {
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"status": "initialized",
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"approved": False,
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"requires_user_interview": True,
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"material_brief_path": "phase1/material_brief.md",
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},
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"phase2": {"status": "pending"},
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"phase3": {"status": "pending"},
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"phase4": {"status": "pending"},
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}
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write_manifest(project_root, manifest)
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_write_interview_seed(project_root, manifest, method)
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write_material_brief(project_root, manifest, method)
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return project_root
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def _write_interview_seed(project_root: Path, manifest: dict[str, Any], method: ResearchMethod) -> None:
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material_text = render_material_inventory(manifest.get("material_inventory") or [])
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text = (
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f"# Phase 1 访谈记录\n\n"
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f"- 主题：{manifest['topic']}\n"
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f"- 研究方法：{method.key} - {method.name}\n"
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f"- 报告类型：{manifest['type']}\n"
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f"- 目标字数：{manifest['target_words']}\n"
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f"- 工作语言：中文主写作；检索关键词、证据摘录和来源笔记可保留英文。\n\n"
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f"## 已提供材料\n\n{material_text}\n\n"
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"## 后续访谈问题\n\n"
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"1. 本报告最重要的决策用途是什么？\n"
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"2. 是否有必须覆盖或必须排除的公司、产品、工艺、市场或法规范围？\n"
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"3. 结论偏好是战略建议、风险清单、投资判断，还是执行路线图？\n"
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)
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(project_root / "phase1" / "interview.md").write_text(text, encoding="utf-8")
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def _material_excerpt(project_root: Path, rel_path: str, *, max_chars: int = 1200) -> str:
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path = project_root / rel_path
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if not path.exists():
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return "（未找到抽取文本）"
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text = path.read_text(encoding="utf-8")
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compact = "\n".join(line.rstrip() for line in text.splitlines() if line.strip())
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return compact[:max_chars] + ("..." if len(compact) > max_chars else "")
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def _derive_material_observations(project_root: Path, inventory: list[dict[str, Any]]) -> list[str]:
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combined_parts: list[str] = []
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for item in inventory:
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rel = item.get("ocr_extracted_to") or item.get("extracted_to")
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if rel and (project_root / rel).exists():
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combined_parts.append((project_root / rel).read_text(encoding="utf-8"))
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text = "\n".join(combined_parts)
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checks = [
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("审计范围覆盖生产管理、原液、制剂和无菌相关模块，报告需要同时处理 GMP 合规、工艺转移和运营协同，而不是只写质量体系。", ["生产管理", "原液", "制剂", "无菌"]),
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("材料显示高风险项为 0、中风险项为 1，适合采用“商业化 readiness 与系统成熟度差距”而非“体系失控”作为初始假设。", ["高风险 0", "中风险1", "低风险7"]),
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("商业化经验、无菌保障细节、文件要求与执行一致性是需要访谈确认的主线风险。", ["商业化经验不足", "无菌保障", "文件要求与执行一致性"]),
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("工艺规程、批记录、CPP/CQA、VMPR/VMP、验证主计划等内容反复出现，说明工艺验证和商业化文件体系可能是 Phase 2 的重点证据轴。", ["CPP", "CQA", "VMPR", "VMP"]),
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("温度、压差、WFI、冷却段微生物、RABS/ORABS、first air、APS 等无菌和设施细节需要映射到 EU Annex 1、NMPA GMP 和企业 SOP。", ["温度", "压差", "WFI", "APS"]),
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("复盘材料包含责任人和局部答复，后续整改路线图应尽量回填 owner、期限、关闭证据和复核机制。", ["填写人", "是否已经回答完整", "整改"]),
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]
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observations = [message for message, needles in checks if any(needle in text for needle in needles)]
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return observations or ["材料已导入但尚未形成足够结构化判断；需要先访谈确认研究用途、范围和优先级。"]
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def write_material_brief(
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project_root: Path,
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manifest: dict[str, Any] | None = None,
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method: ResearchMethod | None = None,
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) -> Path:
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"""Write a Phase 0/1 material brief that must be reviewed before Phase 2."""
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manifest = manifest or load_manifest(project_root)
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method = method or ResearchMethodRegistry().get(manifest.get("research_method"))
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inventory = manifest.get("material_inventory") or []
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lines = [
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f"# Phase 0 材料简报：{manifest.get('topic', project_root.name)}",
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"",
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"status: 待用户确认",
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f"research_method: {method.key}",
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"",
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"## 已导入材料",
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"",
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render_material_inventory(inventory),
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"",
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"## 材料初步解读",
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"",
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"以下内容由 Python core 从已落盘材料抽样生成，只作为访谈起点；不得直接视为最终结论。",
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"",
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]
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lines.extend(["## 初步问题聚类（待访谈确认）", ""])
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for observation in _derive_material_observations(project_root, inventory):
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lines.append(f"- {observation}")
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lines.append("")
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lines.append("## 材料摘录")
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lines.append("")
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for item in inventory:
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rel = item.get("ocr_extracted_to") or item.get("extracted_to")
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if not rel:
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continue
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lines.extend(
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[
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f"### {Path(rel).name}",
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"",
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_material_excerpt(project_root, rel),
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"",
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]
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)
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lines.extend(
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[
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"## 建议访谈确认点",
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"",
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"1. 本报告的最重要用途是什么：内部整改、客户沟通、董事会决策，还是外部审计准备？",
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"2. 哪些审计发现最需要优先展开：无菌保障、工艺验证、数据完整性、质量体系闭环，还是运营协同？",
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"3. 是否存在必须排除或脱敏的项目、人员、客户、产品或工艺信息？",
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"4. 短中长期整改的时间边界如何定义，例如 30/90/180 天，还是按临床/商业化里程碑划分？",
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"5. 是否需要把 NMPA、FDA、EMA、ICH、WHO 的法规基线分别映射到整改责任人和证据包？",
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"",
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"## Gate",
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"",
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"请用户确认本材料简报与访谈问题后，再生成或批准 `phase1/framework.md` 并进入 Phase 2。",
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"",
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]
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)
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out = project_root / "phase1" / "material_brief.md"
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out.parent.mkdir(parents=True, exist_ok=True)
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out.write_text("\n".join(lines), encoding="utf-8")
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return out
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CHAPTER_TEMPLATES: dict[str, list[str]] = {
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"mckinsey_market": [
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"核心结论先行界定市场机会与约束",
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"临床与真实世界证据决定需求天花板",
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"监管路径和支付环境重塑商业化节奏",
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"竞争格局正在从单点产品转向组合能力",
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"专利与技术壁垒决定长期利润池",
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"中国市场的准入和供给能力形成独立变量",
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"资本市场预期与基本面之间存在可验证偏差",
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"反方证据限定结论边界并提示回撤风险",
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"战略选择应围绕资源约束排序",
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"执行路线图需要把证据缺口转化为行动清单",
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],
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"gmp_gap_assessment": [
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"监管基线决定整改范围而非企业主观偏好",
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"现状差距需要按法规条款和业务流程双重定位",
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"质量风险分级决定 CAPA 优先级",
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"根因分析质量决定整改能否闭环",
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"CAPA 设计必须绑定责任人、证据和期限",
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"验证计划决定整改是否可被审计接受",
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"供应商和外包管理常是系统性缺口放大器",
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"数据完整性风险需要独立成章处理",
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"实施路线图需要平衡停线风险与合规风险",
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"管理层治理机制决定整改能否持续",
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],
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"cmc_process_risk": [
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"工艺流程图是识别放大风险的起点",
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"CQA 与 CPP 的映射决定控制策略质量",
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"放大过程的失效模式集中在传质、混合和稳定性",
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"分析方法和放行标准决定证据可信度",
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"技术转移风险来自知识隐性化和现场差异",
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"供应链约束会改变工艺控制边界",
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"偏差和变更管理决定商业化后的韧性",
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"监管沟通策略需要提前固化关键假设",
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"反方证据限定平台工艺可复制性",
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"CMC 路线图需要把风险转化为验证实验",
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],
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"rd_go_no_go": [
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"科学假设强度决定项目是否值得进入下一阶段",
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"POC 证据需要同时证明有效性和可转化性",
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"安全性窗口决定适应症与人群选择",
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"IP 与 FTO 风险决定商业化自由度",
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"开发路径需要把关键不确定性前置验证",
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"竞争窗口决定速度是否仍有战略价值",
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"CMC 与临床运营能力影响真实可行性",
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"反方证据决定 go/no-go 阈值",
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"投资强度应与证据成熟度匹配",
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"决策门槛需要形成可执行检查表",
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],
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"management_consulting": [
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"现状诊断需要区分症状、根因和约束条件",
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"能力差距决定组织改进优先级",
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"流程断点揭示跨部门协作成本",
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"治理结构决定决策速度和责任清晰度",
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"运营模型需要匹配战略目标而非照搬标杆",
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"数字化工具只有嵌入流程才产生价值",
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"绩效指标需要避免局部最优",
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"变革阻力本身是方案设计输入",
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"路线图需要把 quick wins 与系统建设分层",
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"落地机制决定咨询建议能否转化为成果",
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],
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"gmp_quality_operations_diagnosis": [
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"现场审计发现需要先转化为可验证的系统性问题图谱",
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"法规基线决定质量体系差距的严重度与整改边界",
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"生产工艺体系风险来自流程、设施、公用系统和验证证据的耦合缺口",
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"偏差、变更、CAPA 和数据完整性决定质量系统能否闭环",
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"人员能力与质量文化决定制度是否真正落地",
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"运营管理问题需要区分组织、流程、会议机制和指标体系缺口",
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"跨部门协同断点会放大 GMP 风险和交付风险",
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"标杆实践应转化为短中长期整改组合而非口号",
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"整改路线图必须绑定责任、优先级、证据和复核机制",
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"管理层治理机制决定白帆能否从一次整改转向持续改进",
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],
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}
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def render_framework(project_root: Path, *, method_key: str | None = None, chapter_count: int = 10) -> Path:
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manifest = load_manifest(project_root)
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registry = ResearchMethodRegistry()
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method = registry.get(method_key or manifest.get("research_method"))
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if method_key:
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manifest["research_method"] = method.key
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titles = CHAPTER_TEMPLATES.get(method.key) or CHAPTER_TEMPLATES["mckinsey_market"]
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chapter_count = max(8, min(15, chapter_count))
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selected = titles[:chapter_count]
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quota = max(800, int(manifest.get("target_words", 30000)) // len(selected))
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sections = "\n".join(f"- {item}" for item in method.framework_sections)
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axes = "、".join(method.task_axes)
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material_text = render_material_inventory(manifest.get("material_inventory") or [])
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lines = [
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f"# {manifest.get('report_title') or manifest['topic']}：研究框架",
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"",
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f"research_method: {method.key}",
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f"method_name: {method.name}",
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f"work_language: 中文主写作；检索关键词、证据摘录、source title、raw notes 可保留英文。",
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f"target_words: {manifest.get('target_words', 30000)}",
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"",
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"## 方法选择",
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"",
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f"本项目采用 `{method.key}`，因为其结构原则是：{method.structure_principle}",
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"",
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"框架模块：",
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sections,
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"",
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"Phase 2 任务轴：",
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f"- {axes}",
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"",
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"## 输入材料与使用边界",
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"",
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material_text,
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"",
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"这些材料作为现场问题线索和内部事实起点使用；正式结论仍需结合 NMPA、FDA、EMA、ICH、WHO 等权威法规、指南和最佳实践进行验证。",
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"",
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"## 中心假设",
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"",
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f"围绕“{manifest['topic']}”形成可被证据支持或证伪的中文主线；所有核心判断必须绑定来源 ID。",
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"",
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]
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for idx, title in enumerate(selected, start=1):
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lines.extend(
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[
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f"## 第{idx}章 {title}",
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"",
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f"建议字数：约 {quota} 字。",
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f"研究思路：围绕 `{method.key}` 的方法框架，从 {axes} 等任务轴并发收集 evidence packet，再由 chapter assembly 收束为完整中文章节。",
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"证据要求：至少 2 个独立 Tier 1-2 信源；不足时在正文标注待验证；必须包含反方证据。",
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"",
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]
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)
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lines.extend(
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[
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"## 暂停点",
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"",
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"请先确认 `phase1/material_brief.md` 的材料解读和访谈问题，再确认本框架后进入 Phase 2。若章节逻辑、方法框架或字数配额需要调整，应先修改本文件。",
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"",
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"确认后运行：`uv run python scripts/dr.py approve <project>`；未批准时 `research` 默认会拒绝推进，可用 `--force` 临时覆盖。",
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"",
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]
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)
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out = project_root / "phase1" / "framework.md"
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out.parent.mkdir(parents=True, exist_ok=True)
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out.write_text("\n".join(lines), encoding="utf-8")
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manifest["phase1"] = {
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"status": "completed",
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"approved": False,
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"framework_path": "phase1/framework.md",
|
|
"research_method": method.key,
|
|
"updated_at": utc_now_iso(),
|
|
}
|
|
manifest["updated_at"] = utc_now_iso()
|
|
write_manifest(project_root, manifest)
|
|
return out
|