764 lines
45 KiB
Python
764 lines
45 KiB
Python
#!/usr/bin/env python3
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# -*- coding: utf-8 -*-
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"""
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Generate formal meeting minutes PDF for Yugong Biotech audit remediation.
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"""
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from reportlab.lib.pagesizes import A4
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from reportlab.lib import colors
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from reportlab.lib.units import cm
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from reportlab.lib.styles import ParagraphStyle
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from reportlab.platypus import (
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SimpleDocTemplate, Paragraph, Spacer, Table, TableStyle,
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HRFlowable, KeepTogether
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)
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from reportlab.pdfbase import pdfmetrics
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from reportlab.pdfbase.ttfonts import TTFont
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from reportlab.lib.enums import TA_CENTER, TA_LEFT, TA_JUSTIFY
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import os
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# ── 字体注册 ──────────────────────────────────────────────────────────────────
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pdfmetrics.registerFont(TTFont('STHeiti', '/System/Library/Fonts/STHeiti Medium.ttc', subfontIndex=0))
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pdfmetrics.registerFont(TTFont('STHeitiLight', '/System/Library/Fonts/STHeiti Light.ttc', subfontIndex=0))
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# ── 颜色定义 ──────────────────────────────────────────────────────────────────
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DARK_BLUE = colors.HexColor('#1B3A6B')
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MID_BLUE = colors.HexColor('#2E6DA4')
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LIGHT_BLUE = colors.HexColor('#D6E4F0')
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RED_CRIT = colors.HexColor('#C0392B')
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ORANGE_MAJ = colors.HexColor('#E67E22')
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YELLOW_MIN = colors.HexColor('#F1C40F')
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BG_CRIT = colors.HexColor('#FADBD8')
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BG_MAJ = colors.HexColor('#FDEBD0')
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BG_MIN = colors.HexColor('#FEF9E7')
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BG_HEAD = colors.HexColor('#EBF5FB')
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GRAY_LINE = colors.HexColor('#BDC3C7')
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WHITE = colors.white
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DARK_GRAY = colors.HexColor('#2C3E50')
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LIGHT_GRAY = colors.HexColor('#F2F3F4')
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# ── 段落样式 ──────────────────────────────────────────────────────────────────
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def make_styles():
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base = {'fontName': 'STHeiti', 'leading': 16}
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return {
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'title': ParagraphStyle('title',
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fontName='STHeiti', fontSize=16, leading=22,
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alignment=TA_CENTER, textColor=WHITE, spaceAfter=4),
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'subtitle': ParagraphStyle('subtitle',
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fontName='STHeitiLight', fontSize=8.5, leading=13,
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alignment=TA_CENTER, textColor=colors.HexColor('#D6EAF8'), spaceAfter=2),
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'section': ParagraphStyle('section',
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fontName='STHeiti', fontSize=12, leading=18,
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textColor=WHITE, spaceBefore=6, spaceAfter=4),
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'subsection': ParagraphStyle('subsection',
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fontName='STHeiti', fontSize=10.5, leading=16,
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textColor=DARK_BLUE, spaceBefore=8, spaceAfter=4),
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'body': ParagraphStyle('body',
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fontName='STHeitiLight', fontSize=9.5, leading=15,
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textColor=DARK_GRAY, spaceAfter=3, alignment=TA_LEFT),
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'body_bold': ParagraphStyle('body_bold',
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fontName='STHeiti', fontSize=9.5, leading=15,
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textColor=DARK_GRAY, spaceAfter=3),
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'cell': ParagraphStyle('cell',
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fontName='STHeitiLight', fontSize=8.5, leading=13,
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textColor=DARK_GRAY),
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'cell_bold': ParagraphStyle('cell_bold',
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fontName='STHeiti', fontSize=8.5, leading=13,
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textColor=DARK_GRAY),
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'cell_crit': ParagraphStyle('cell_crit',
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fontName='STHeiti', fontSize=8.5, leading=13,
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textColor=RED_CRIT),
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'cell_maj': ParagraphStyle('cell_maj',
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fontName='STHeiti', fontSize=8.5, leading=13,
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textColor=ORANGE_MAJ),
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'cell_min': ParagraphStyle('cell_min',
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fontName='STHeiti', fontSize=8.5, leading=13,
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textColor=colors.HexColor('#9B7D11')),
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'footer': ParagraphStyle('footer',
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fontName='STHeitiLight', fontSize=7.5, leading=11,
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textColor=colors.HexColor('#7F8C8D'), alignment=TA_CENTER),
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'cell_header': ParagraphStyle('cell_header',
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fontName='STHeiti', fontSize=8.5, leading=13,
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textColor=WHITE),
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'reg_title': ParagraphStyle('reg_title',
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fontName='STHeiti', fontSize=9.5, leading=14,
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textColor=MID_BLUE, spaceAfter=2),
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'bullet': ParagraphStyle('bullet',
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fontName='STHeitiLight', fontSize=9, leading=14,
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textColor=DARK_GRAY, leftIndent=12, spaceAfter=2),
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}
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S = make_styles()
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# ── 辅助：带背景色的节标题 ────────────────────────────────────────────────────
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def section_header(text, color=MID_BLUE, text_style='section'):
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data = [[Paragraph(text, S[text_style])]]
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t = Table(data, colWidths=[17.5*cm])
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t.setStyle(TableStyle([
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('BACKGROUND', (0,0), (-1,-1), color),
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('TOPPADDING', (0,0), (-1,-1), 5),
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('BOTTOMPADDING', (0,0), (-1,-1), 5),
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('LEFTPADDING', (0,0), (-1,-1), 10),
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('RIGHTPADDING', (0,0), (-1,-1), 10),
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('ROWBACKGROUNDS', (0,0), (-1,-1), [color]),
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]))
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return t
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def info_table(rows):
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"""Two-column key-value table for meeting info."""
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data = [[Paragraph(k, S['cell_bold']), Paragraph(v, S['cell'])]
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for k, v in rows]
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t = Table(data, colWidths=[3.8*cm, 13.7*cm])
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t.setStyle(TableStyle([
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('BACKGROUND', (0,0), (0,-1), BG_HEAD),
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('BACKGROUND', (1,0), (1,-1), WHITE),
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('GRID', (0,0), (-1,-1), 0.4, GRAY_LINE),
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('TOPPADDING', (0,0), (-1,-1), 4),
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('BOTTOMPADDING', (0,0), (-1,-1), 4),
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('LEFTPADDING', (0,0), (-1,-1), 6),
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('RIGHTPADDING', (0,0), (-1,-1), 6),
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('VALIGN', (0,0), (-1,-1), 'TOP'),
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]))
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return t
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# ── 主文档构建 ────────────────────────────────────────────────────────────────
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def build_pdf(output_path):
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doc = SimpleDocTemplate(
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output_path,
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pagesize=A4,
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leftMargin=2.0*cm, rightMargin=2.0*cm,
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topMargin=2.2*cm, bottomMargin=2.2*cm,
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title='愚公生物（百时美）供应商审计整改会议纪要',
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author='愚公生物科技有限公司 质量管理部',
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)
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story = []
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W = 17.5 * cm # 可用宽度
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# ═══════════════════════════════════════════════════════════════════════════
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# 封面标题区
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# ═══════════════════════════════════════════════════════════════════════════
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cover_data = [
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[Paragraph('愚公生物科技有限公司（百时美）', S['subtitle'])],
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[Paragraph('供应商审计问题复盘与质量整改专项会议纪要', S['title'])],
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[Paragraph('SUPPLIER AUDIT REMEDIATION — INTERNAL MEETING MINUTES', S['subtitle'])],
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[Paragraph('文件编号：YG-QA-MOM-2026-001 版本：V1.0 密级：内部', S['subtitle'])],
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]
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cover_t = Table(cover_data, colWidths=[W])
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cover_t.setStyle(TableStyle([
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('BACKGROUND', (0,0), (-1,-1), DARK_BLUE),
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('TOPPADDING', (0,0), (-1,-1), 12),
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('BOTTOMPADDING', (0,0), (-1,-1), 12),
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('LEFTPADDING', (0,0), (-1,-1), 14),
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('RIGHTPADDING', (0,0), (-1,-1), 14),
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]))
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story.append(cover_t)
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story.append(Spacer(1, 0.4*cm))
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# ═══════════════════════════════════════════════════════════════════════════
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# 一、会议基本信息
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# ═══════════════════════════════════════════════════════════════════════════
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story.append(section_header('一、会议基本信息'))
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story.append(Spacer(1, 0.2*cm))
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story.append(info_table([
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('会议主题', '申基供应商审计问题复盘、质量体系整改及 4000 万订单配合工作'),
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('会议日期', '2026 年 4 月 10 日'),
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('会议地点', '愚公生物科技有限公司 会议室'),
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('主持人', '任宏杰（说话人 A）'),
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('参会人员', '任宏杰（A，主持）、二袁（B）、说话人 C、毕海（D）、说话人 E'),
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('记录人', '质量管理部'),
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('核心背景', '申基承接制药企业 CDMO 业务，委托愚公生物生产关键工具酶原料。\n'
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'申基依其客户要求对愚公生物开展现场供应商审计，发现若干缺陷。\n'
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'本次会议为愚公生物内部复盘，制定整改方案与行动计划。\n'
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'4000 万元订单执行不受本次审计直接影响，各方共担提考连带责任。'),
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]))
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story.append(Spacer(1, 0.5*cm))
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# ═══════════════════════════════════════════════════════════════════════════
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# 二、适用质量法规体系综述
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# ═══════════════════════════════════════════════════════════════════════════
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story.append(section_header('二、酶类原料供应商适用质量法规体系综述'))
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story.append(Spacer(1, 0.25*cm))
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story.append(Paragraph('2.1 原料定位判断', S['subsection']))
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story.append(Paragraph(
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'愚公生物生产的工具酶（含 RI 核糖核酸酶抑制剂等）在申基 CDMO 场景中，以工艺辅助或关键'
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'原料身份介入药物生产，<b>不作为最终药品活性成分（API）存在于制成品中</b>。依据 ICH Q7、'
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'IPEC-PQG GMP 指南及 FDA/EMA 相关指导原则，其定位层级如下：',
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S['body']))
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pos_data = [
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[Paragraph('定位层级', S['cell_header']),
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Paragraph('判断依据', S['cell_header']),
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Paragraph('适用情景', S['cell_header']),
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Paragraph('适用标准', S['cell_header'])],
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[Paragraph('API 起始物料\n（API Starting Material）', S['cell']),
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Paragraph('酶直接掺入 API 结构，或残留物影响 API 关键质量属性（CQAs）', S['cell']),
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Paragraph('酶参与关键化学反应步骤，残留显著影响杂质谱', S['cell']),
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Paragraph('ICH Q7 全文、供应商审计、DMF 备案', S['cell'])],
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[Paragraph('关键原料 / 工艺助剂\n（Critical Reagent）\n★ 当前最可能定位', S['cell_bold']),
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Paragraph('酶仅参与上游工艺步骤，最终产品中不含酶活或酶蛋白；\n但其质量直接影响产品 CQA（如活性、纯度、内毒素）', S['cell']),
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Paragraph('RI 酶用于 mRNA/蛋白合成工艺，\n纯化后被去除', S['cell']),
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Paragraph('ICH Q7（原材料章节）、IPEC-PQG GMP（基础）、\nISO 9001:2015、质量协议（QA）', S['cell'])],
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[Paragraph('辅料 / 工艺助剂\n（Excipient/Processing Aid）', S['cell']),
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Paragraph('酶以非治疗性功能加入制剂，如增稠、稳定等', S['cell']),
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Paragraph('较少见于工具酶场景', S['cell']),
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Paragraph('IPEC-PQG GMP、EXCiPACT 认证、ISO 9001', S['cell'])],
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]
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pos_t = Table(pos_data, colWidths=[3.5*cm, 5*cm, 4*cm, 5*cm])
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pos_t.setStyle(TableStyle([
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('BACKGROUND', (0,0), (-1,0), DARK_BLUE),
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('TEXTCOLOR', (0,0), (-1,0), WHITE),
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('FONTNAME', (0,0), (-1,0), 'STHeiti'),
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('BACKGROUND', (0,2), (-1,2), LIGHT_BLUE),
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('GRID', (0,0), (-1,-1), 0.4, GRAY_LINE),
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('TOPPADDING', (0,0), (-1,-1), 4),
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('BOTTOMPADDING', (0,0), (-1,-1), 4),
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('LEFTPADDING', (0,0), (-1,-1), 5),
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('RIGHTPADDING', (0,0), (-1,-1), 5),
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('VALIGN', (0,0), (-1,-1), 'TOP'),
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('ROWBACKGROUNDS', (0,1), (-1,-1), [WHITE, LIGHT_BLUE, WHITE]),
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]))
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story.append(pos_t)
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story.append(Spacer(1, 0.3*cm))
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story.append(Paragraph('2.2 核心适用法规框架', S['subsection']))
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reg_rows = [
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('ICH Q7\n（API GMP）', 'GMP 原材料章节要求供应商评估与批准；关键原材料须执行三批次全检基准测试；质量协议中须明确检验方法、CoA 要求、供应商变更通知条款。'),
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('IPEC-PQG GMP 指南\n（辅料/关键原料）', '适用于药物辅料及工艺助剂生产商；要求在工艺中"有理可循"的节点执行 GMP；覆盖文件管理、变更控制、偏差管理、清洁验证、稳定性研究。与 ISO 9001 互补。'),
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('ISO 9001:2015\n（质量管理体系）', '作为最低基线的质量管理体系；涵盖记录控制、不合格品管理、持续改进、内审等。不能替代药品 GMP，但为药企客户审计的基础期望。'),
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('中国 NMPA\n相关法规', '《原辅料及直接接触药品包装材料供应商审计指南》（2020年）：药企须对关键原辅料供应商定期审计；供应商须具备与产品风险相称的质量体系；原辅料变更须履行评估与报告程序。'),
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('质量协议（QA）\n与供应商资质', '申基作为 CDMO 依托其下游客户要求，须与愚公生物签订正式质量协议，约定：CoA 内容与放行标准、审计权利、变更通知时限、可溯源性要求、稳定性和储存条件、内毒素/生物负载限度。'),
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('关键检测要求\n（酶原料特有）', '活性（RI 活性等效力测定）、纯度（SEC-HPLC）、内毒素（LAL）、生物负载（TAMC/TYMC）、宿主细胞蛋白（HCP）、残余 DNA、重金属；稳定性数据（支持储存条件）。'),
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]
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for title, content in reg_rows:
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data = [[Paragraph(title, S['reg_title']), Paragraph(content, S['cell'])]]
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t = Table(data, colWidths=[3.8*cm, 13.7*cm])
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t.setStyle(TableStyle([
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('BACKGROUND', (0,0), (0,-1), BG_HEAD),
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('GRID', (0,0), (-1,-1), 0.4, GRAY_LINE),
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('TOPPADDING', (0,0), (-1,-1), 5),
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||
('BOTTOMPADDING', (0,0), (-1,-1), 5),
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||
('LEFTPADDING', (0,0), (-1,-1), 6),
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('RIGHTPADDING', (0,0), (-1,-1), 6),
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('VALIGN', (0,0), (-1,-1), 'TOP'),
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]))
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story.append(t)
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story.append(Spacer(1, 0.15*cm))
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||
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story.append(Paragraph(
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'结论：愚公生物作为药物关键工具酶原料供应商，不必全面执行药品 GMP（21 CFR Part 211 或《药品生产质量管理规范》），'
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'但须建立并有效运行<b>以 ISO 9001 为基础、参照 IPEC-PQG GMP 指南核心要求的质量体系</b>，并满足申基及其客户在'
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'质量协议中约定的特定要求，包括：数据完整性、验证体系、关键参数检测（尤其 RI 活性）及稳定性研究。',
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S['body']))
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story.append(Spacer(1, 0.5*cm))
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||
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||
# ═══════════════════════════════════════════════════════════════════════════
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# 三、审计缺陷项分级分析
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# ═══════════════════════════════════════════════════════════════════════════
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story.append(section_header('三、审计缺陷项严重等级分析'))
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story.append(Spacer(1, 0.2*cm))
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|
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# 分级说明
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legend_data = [
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[Paragraph('严重（Critical）', S['cell_crit']),
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Paragraph('重大（Major）', S['cell_maj']),
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Paragraph('一般（Minor）', S['cell_min'])],
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[Paragraph('直接危及产品质量/安全性，或存在系统性数据诚信问题，不可接受，须立即整改', S['cell']),
|
||
Paragraph('显著违反质量体系要求，可能导致产品质量问题，须限期整改', S['cell']),
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||
Paragraph('程序性缺陷，当前影响有限，须计划整改', S['cell'])],
|
||
]
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legend_t = Table(legend_data, colWidths=[W/3, W/3, W/3])
|
||
legend_t.setStyle(TableStyle([
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||
('BACKGROUND', (0,0), (0,-1), BG_CRIT),
|
||
('BACKGROUND', (1,0), (1,-1), BG_MAJ),
|
||
('BACKGROUND', (2,0), (2,-1), BG_MIN),
|
||
('GRID', (0,0), (-1,-1), 0.4, GRAY_LINE),
|
||
('TOPPADDING', (0,0), (-1,-1), 5),
|
||
('BOTTOMPADDING', (0,0), (-1,-1), 5),
|
||
('LEFTPADDING', (0,0), (-1,-1), 6),
|
||
('RIGHTPADDING', (0,0), (-1,-1), 6),
|
||
('VALIGN', (0,0), (-1,-1), 'TOP'),
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||
('ALIGN', (0,0), (-1,0), 'CENTER'),
|
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]))
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story.append(legend_t)
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||
story.append(Spacer(1, 0.35*cm))
|
||
|
||
# ── 3.1 严重缺陷 ──────────────────────────────────────────────────────────
|
||
story.append(section_header('3.1 严重缺陷（Critical）', color=RED_CRIT))
|
||
story.append(Spacer(1, 0.2*cm))
|
||
|
||
crit_header = [
|
||
Paragraph('编号', S['cell_header']),
|
||
Paragraph('缺陷描述', S['cell_header']),
|
||
Paragraph('法规依据', S['cell_header']),
|
||
Paragraph('风险说明', S['cell_header']),
|
||
]
|
||
crit_items = [
|
||
('C-01', '系统性记录造假与数据完整性严重缺失',
|
||
'记录普遍事后补写；一批生产对应三批数据；温湿度/压差辅助记录迎审时统一补填，笔迹一眼可辨，与主批记录时间矛盾；批记录存在明显造假痕迹。',
|
||
'ICH Q7 第 6 章；IPEC-PQG GMP 4.5；ISO 9001 7.5；FDA Data Integrity Guidance（2018）',
|
||
'数据诚信（Data Integrity）是 GMP/质量体系的核心基石。系统性造假导致审计方对所有数据完全不信任，无法证明产品质量受控，直接危及下游客户的药品申报。'),
|
||
('C-02', 'RI 活性检测能力缺失，未纳入质量标准',
|
||
'生产端荧光仪无法检测 RI 活性；RI 活性效力测定未纳入原酶及成品质量标准；无法证明每批产品活性符合要求。',
|
||
'ICH Q7 11.1；IPEC-PQG GMP 8.1；FDA Potency Guidance；质量协议约定检测项目',
|
||
'RI 活性是该产品的核心关键质量属性（CQA）。无活性检测即无法保证产品功能一致性，直接影响客户药物工艺结果，属最高级别产品质量风险。'),
|
||
('C-03', '清洁验证严重缺失（交叉污染风险）',
|
||
'100+ 品种共线生产，无任何残留限度设定、无棉签回收率验证、无中转容器清洁验证；无法证明产品间无交叉污染。',
|
||
'IPEC-PQG GMP 6.4；ICH Q7 第 12 章；EU GMP Annex 15',
|
||
'多品种共线而无清洁验证，存在产品间交叉污染的实质性风险，可能导致客户产品出现工艺外源污染物，危及药品安全性与有效性。'),
|
||
]
|
||
|
||
for code, title, desc, ref, risk in crit_items:
|
||
header_row = [
|
||
Paragraph(f'<b>{code}</b>', S['cell_crit']),
|
||
Paragraph(f'<b>{title}</b>', S['cell_crit']),
|
||
Paragraph('', S['cell']),
|
||
Paragraph('', S['cell']),
|
||
]
|
||
desc_row = [
|
||
Paragraph('缺陷描述', S['cell_bold']),
|
||
Paragraph(desc, S['cell']),
|
||
Paragraph('法规依据', S['cell_bold']),
|
||
Paragraph(ref, S['cell']),
|
||
]
|
||
risk_row = [
|
||
Paragraph('风险说明', S['cell_bold']),
|
||
Paragraph(risk, S['cell']),
|
||
Paragraph('', S['cell']),
|
||
Paragraph('', S['cell']),
|
||
]
|
||
t = Table([header_row, desc_row, risk_row],
|
||
colWidths=[1.8*cm, 6.8*cm, 2*cm, 6.9*cm])
|
||
t.setStyle(TableStyle([
|
||
('BACKGROUND', (0,0), (-1,0), BG_CRIT),
|
||
('BACKGROUND', (0,1), (0,-1), LIGHT_GRAY),
|
||
('BACKGROUND', (2,1), (2,-1), LIGHT_GRAY),
|
||
('GRID', (0,0), (-1,-1), 0.4, GRAY_LINE),
|
||
('SPAN', (1,0), (3,0)),
|
||
('SPAN', (1,2), (3,2)),
|
||
('TOPPADDING', (0,0), (-1,-1), 4),
|
||
('BOTTOMPADDING', (0,0), (-1,-1), 4),
|
||
('LEFTPADDING', (0,0), (-1,-1), 5),
|
||
('RIGHTPADDING', (0,0), (-1,-1), 5),
|
||
('VALIGN', (0,0), (-1,-1), 'TOP'),
|
||
]))
|
||
story.append(KeepTogether([t, Spacer(1, 0.2*cm)]))
|
||
|
||
# ── 3.2 重大缺陷 ──────────────────────────────────────────────────────────
|
||
story.append(Spacer(1, 0.15*cm))
|
||
story.append(section_header('3.2 重大缺陷（Major）', color=ORANGE_MAJ))
|
||
story.append(Spacer(1, 0.2*cm))
|
||
|
||
maj_items = [
|
||
('M-01', '文件体系不具可执行性，照搬药企模板',
|
||
'文件大量照搬恒瑞/天晴模板，与公司实际人力、产能、工艺严重不符；存在替换页、纸张颜色不一致等低级错误；文件被审计方整体质疑。',
|
||
'IPEC-PQG GMP 4.1；ISO 9001 7.5；ICH Q7 第 6 章'),
|
||
('M-02', '文件发放、接收、销毁流程缺失，虚拟执行',
|
||
'无接收人记录、文件名错误、发放流程形同虚设；存在虚拟执行痕迹（文件从未真实流转）。',
|
||
'IPEC-PQG GMP 4.2；ICH Q7 6.5；ISO 9001 7.5.3'),
|
||
('M-03', '偏差/OOS/OOT 管理体系完全缺失',
|
||
'无任何偏差、超标（OOS）、超趋势（OOT）记录与处理程序；审计方判定"产品是检出来的，不是生产出来的"。',
|
||
'ICH Q7 第 15 章；IPEC-PQG GMP 5.2；FDA OOS Guidance（2006）'),
|
||
('M-04', '工艺验证报告不可信，关键参数未覆盖',
|
||
'工艺验证报告未覆盖关键工艺参数、收率及内毒素去除效率；批记录与工艺规程描述不一致；纯化多峰即收，无固定标准。',
|
||
'ICH Q7 第 12 章；IPEC-PQG GMP 7.1；EU GMP Annex 15'),
|
||
('M-05', '稳定性研究缺失，产品全生命周期数据空白',
|
||
'原酶未开展稳定性研究；现有方案设计不合理（25℃放置 12 个月，不符合酶类特性）；无法为储存条件和效期提供数据支撑。',
|
||
'ICH Q1A(R2)；IPEC-PQG GMP 8.2；ICH Q7 11.6'),
|
||
('M-06', 'QA/QC 人员专业能力严重不足，QA 负责人不称职',
|
||
'QA/QC 团队多为外行，不了解酶行业特性；QA 负责人言语轻浮、以第三方心态应对客户，现场被当场质疑；人员一人多岗，审计方直接判定数据不可信。',
|
||
'ICH Q7 第 2 章；IPEC-PQG GMP 3.2；ISO 9001 7.2'),
|
||
('M-07', '关键设备缺失，设备标识不全',
|
||
'缺少灭菌锅、干燥箱等必要设备；砝码、设备标识不全；荧光仪无法满足 RI 活性检测要求。',
|
||
'ICH Q7 第 5 章；IPEC-PQG GMP 6.1；ISO 9001 7.1'),
|
||
('M-08', '酶与 buffer 未分离管理，不符合规范',
|
||
'酶与 buffer 混合管理，无独立稳定性和质量控制；不符合 GMP/IPEC 产品分类管理规范。',
|
||
'IPEC-PQG GMP 5.1；ICH Q7 11.2'),
|
||
]
|
||
|
||
maj_header = [
|
||
Paragraph('编号', S['cell_header']),
|
||
Paragraph('缺陷名称', S['cell_header']),
|
||
Paragraph('缺陷描述', S['cell_header']),
|
||
Paragraph('法规依据', S['cell_header']),
|
||
]
|
||
maj_data = [maj_header] + [
|
||
[Paragraph(f'<b>{c}</b>', S['cell_maj']),
|
||
Paragraph(f'<b>{t}</b>', S['cell_bold']),
|
||
Paragraph(d, S['cell']),
|
||
Paragraph(r, S['cell'])]
|
||
for c, t, d, r in maj_items
|
||
]
|
||
maj_t = Table(maj_data, colWidths=[1.5*cm, 3.5*cm, 7.8*cm, 4.7*cm])
|
||
maj_t.setStyle(TableStyle([
|
||
('BACKGROUND', (0,0), (-1,0), ORANGE_MAJ),
|
||
('TEXTCOLOR', (0,0), (-1,0), WHITE),
|
||
('FONTNAME', (0,0), (-1,0), 'STHeiti'),
|
||
('ROWBACKGROUNDS', (0,1), (-1,-1), [WHITE, BG_MAJ]),
|
||
('GRID', (0,0), (-1,-1), 0.4, GRAY_LINE),
|
||
('TOPPADDING', (0,0), (-1,-1), 4),
|
||
('BOTTOMPADDING', (0,0), (-1,-1), 4),
|
||
('LEFTPADDING', (0,0), (-1,-1), 5),
|
||
('RIGHTPADDING', (0,0), (-1,-1), 5),
|
||
('VALIGN', (0,0), (-1,-1), 'TOP'),
|
||
]))
|
||
story.append(maj_t)
|
||
story.append(Spacer(1, 0.35*cm))
|
||
|
||
# ── 3.3 一般缺陷 ──────────────────────────────────────────────────────────
|
||
story.append(section_header('3.3 一般缺陷（Minor）', color=colors.HexColor('#9B7D11')))
|
||
story.append(Spacer(1, 0.2*cm))
|
||
|
||
min_items = [
|
||
('N-01', '现场卫生问题',
|
||
'下水管道锈蚀严重，现场整洁度不达标，影响客户观感与检查结论。',
|
||
'IPEC-PQG GMP 6.3；ISO 9001 7.1'),
|
||
('N-02', '文件低级错误（替换页、颜色不一致）',
|
||
'文件中存在替换页、纸张颜色不一致等低级错误，直接导致文件整体可信度下降。',
|
||
'ICH Q7 6.2；IPEC-PQG GMP 4.2'),
|
||
('N-03', '批记录数据项不完整（缺少计算过程）',
|
||
'批记录中关键数据缺少计算过程记录，数据可追溯性不足（此项与 C-01 系统造假有别，属记录习惯问题）。',
|
||
'ICH Q7 6.4；IPEC-PQG GMP 4.5'),
|
||
]
|
||
|
||
min_header = [
|
||
Paragraph('编号', S['cell_header']),
|
||
Paragraph('缺陷名称', S['cell_header']),
|
||
Paragraph('缺陷描述', S['cell_header']),
|
||
Paragraph('法规依据', S['cell_header']),
|
||
]
|
||
min_data = [min_header] + [
|
||
[Paragraph(f'<b>{c}</b>', S['cell_min']),
|
||
Paragraph(f'<b>{t}</b>', S['cell_bold']),
|
||
Paragraph(d, S['cell']),
|
||
Paragraph(r, S['cell'])]
|
||
for c, t, d, r in min_items
|
||
]
|
||
min_t = Table(min_data, colWidths=[1.5*cm, 3.5*cm, 7.8*cm, 4.7*cm])
|
||
min_t.setStyle(TableStyle([
|
||
('BACKGROUND', (0,0), (-1,0), colors.HexColor('#9B7D11')),
|
||
('TEXTCOLOR', (0,0), (-1,0), WHITE),
|
||
('FONTNAME', (0,0), (-1,0), 'STHeiti'),
|
||
('ROWBACKGROUNDS', (0,1), (-1,-1), [WHITE, BG_MIN]),
|
||
('GRID', (0,0), (-1,-1), 0.4, GRAY_LINE),
|
||
('TOPPADDING', (0,0), (-1,-1), 4),
|
||
('BOTTOMPADDING', (0,0), (-1,-1), 4),
|
||
('LEFTPADDING', (0,0), (-1,-1), 5),
|
||
('RIGHTPADDING', (0,0), (-1,-1), 5),
|
||
('VALIGN', (0,0), (-1,-1), 'TOP'),
|
||
]))
|
||
story.append(min_t)
|
||
story.append(Spacer(1, 0.5*cm))
|
||
|
||
# ═══════════════════════════════════════════════════════════════════════════
|
||
# 四、整改行动计划
|
||
# ═══════════════════════════════════════════════════════════════════════════
|
||
story.append(section_header('四、整改行动计划（CAPA）'))
|
||
story.append(Spacer(1, 0.15*cm))
|
||
story.append(Paragraph(
|
||
'以下行动计划以缺陷严重等级为优先序，明确责任部门/人及预估完成日期。'
|
||
'所有整改措施须由 QA 部门完成审核后方可关闭。',
|
||
S['body']))
|
||
story.append(Spacer(1, 0.25*cm))
|
||
|
||
# ── 4.1 严重缺陷行动项 ────────────────────────────────────────────────────
|
||
story.append(Paragraph('4.1 严重缺陷整改行动项（须立即启动）', S['subsection']))
|
||
|
||
action_header = [
|
||
Paragraph('关联\n缺陷', S['cell_header']),
|
||
Paragraph('行动项', S['cell_header']),
|
||
Paragraph('具体措施', S['cell_header']),
|
||
Paragraph('责任人', S['cell_header']),
|
||
Paragraph('预估完成\n日期', S['cell_header']),
|
||
]
|
||
|
||
crit_actions = [
|
||
('C-01', 'A-01\n禁止事后\n补录并建立\n数据诚信\n管理制度',
|
||
'① 即日起发布内部令：禁止任何形式的事后补录，违者追责\n'
|
||
'② 制定《数据完整性管理程序》，涵盖原始记录、电子数据、审计追踪\n'
|
||
'③ 所有批记录和辅助记录须当日填写，QA 每日抽查\n'
|
||
'④ 对现有库存批记录完整性进行回顾，提出整改方案\n'
|
||
'⑤ 开展全员数据诚信培训（1 次/月）',
|
||
'毕海（QA）\n全员配合', '2026-05-01\n（①②即日起执行）'),
|
||
('C-02', 'A-02\n建立 RI 活\n性检测能力\n并纳入质量\n标准',
|
||
'① 立即协调研发部荧光仪，临时用于 RI 活性检测\n'
|
||
'② 任宏杰负责制定 RI 活性效力测定方案，完成方法验证\n'
|
||
'③ 采购/租赁正式 RI 活性检测设备（二袁负责对接采购）\n'
|
||
'④ 将 RI 活性纳入原酶及成品质量标准，修订 QS 文件\n'
|
||
'⑤ 对历史存档批次进行补充 RI 活性检测（留样检测）',
|
||
'任宏杰（研发）\n二袁（采购）\n新 QA 负责人', '2026-07-15\n（设备临时方案\n2026-05-15）'),
|
||
('C-03', 'A-03\n建立清洁\n验证体系',
|
||
'① 梳理 100+ 品种的共线生产矩阵，按风险分级\n'
|
||
'② 制定《清洁验证主计划》（CVP），明确残留限度计算方法（基于 HBEL/PDE）\n'
|
||
'③ 优先完成高风险品种组合的棉签回收率验证和中转容器清洁验证\n'
|
||
'④ 建立清洁验证记录模板及日常监控程序',
|
||
'毕海（QA）\n新 QA 负责人\n生产部', '2026-08-31\n（CVP 文件\n2026-06-01）'),
|
||
]
|
||
|
||
action_data = [action_header]
|
||
for defect, action, measures, owner, date in crit_actions:
|
||
action_data.append([
|
||
Paragraph(f'<b>{defect}</b>', S['cell_crit']),
|
||
Paragraph(action, S['cell_bold']),
|
||
Paragraph(measures, S['cell']),
|
||
Paragraph(owner, S['cell_bold']),
|
||
Paragraph(date, S['cell_bold']),
|
||
])
|
||
ca_t = Table(action_data, colWidths=[1.5*cm, 2.2*cm, 8.3*cm, 2.5*cm, 3.0*cm])
|
||
ca_t.setStyle(TableStyle([
|
||
('BACKGROUND', (0,0), (-1,0), RED_CRIT),
|
||
('TEXTCOLOR', (0,0), (-1,0), WHITE),
|
||
('FONTNAME', (0,0), (-1,0), 'STHeiti'),
|
||
('ROWBACKGROUNDS', (0,1), (-1,-1), [BG_CRIT, WHITE]),
|
||
('GRID', (0,0), (-1,-1), 0.4, GRAY_LINE),
|
||
('TOPPADDING', (0,0), (-1,-1), 4),
|
||
('BOTTOMPADDING', (0,0), (-1,-1), 4),
|
||
('LEFTPADDING', (0,0), (-1,-1), 5),
|
||
('RIGHTPADDING', (0,0), (-1,-1), 5),
|
||
('VALIGN', (0,0), (-1,-1), 'TOP'),
|
||
]))
|
||
story.append(ca_t)
|
||
story.append(Spacer(1, 0.35*cm))
|
||
|
||
# ── 4.2 重大缺陷行动项 ────────────────────────────────────────────────────
|
||
story.append(Paragraph('4.2 重大缺陷整改行动项', S['subsection']))
|
||
|
||
maj_actions = [
|
||
('M-01\nM-02', 'A-04\n重建文件\n管理体系',
|
||
'① 全面梳理现有文件，废止不可执行的模板，重新编写贴合公司实际的 SOP\n'
|
||
'② 建立文件发放、接收、销毁的纸质/电子台账，保留完整签字痕迹\n'
|
||
'③ 统一文件格式、纸张规格，消除低级错误\n'
|
||
'④ 新 QA 负责人牵头，每季度开展文件适用性审查',
|
||
'新 QA 负责人\n毕海', '2026-06-30'),
|
||
('M-03', 'A-05\n建立偏差/\nOOS/OOT\n管理程序',
|
||
'① 编写《偏差管理规程》《OOS 调查程序》《OOT 趋势分析程序》\n'
|
||
'② 对历史生产数据进行回顾，识别并补充登记已发生的偏差/OOS\n'
|
||
'③ 对 QA/QC 人员开展专项培训',
|
||
'新 QA 负责人', '2026-06-15'),
|
||
('M-04', 'A-06\n完善工艺\n验证报告',
|
||
'① 补充工艺验证报告中关键工艺参数（KPP）、收率、内毒素去除效率数据\n'
|
||
'② 制定固定纯化标准（收峰标准），与工艺规程保持一致\n'
|
||
'③ 执行至少 3 批次连续工艺验证，确保批次间一致性',
|
||
'任宏杰（研发）\n生产部\n新 QA 负责人', '2026-08-31'),
|
||
('M-05', 'A-07\n启动稳定性\n研究',
|
||
'① 制定《原酶稳定性研究方案》：检测项目简化为酶活性 + 内毒素，避免过度冗余\n'
|
||
'② 参照 ICH Q1A 条件（2-8℃实时 + 25℃加速），启动长期稳定性研究\n'
|
||
'③ 酶与 buffer 分开单独开展稳定性研究\n'
|
||
'④ 稳定性数据支持质量标准中的效期和储存条件设定',
|
||
'任宏杰（研发）\n新 QA 负责人', '2026-07-31\n（方案批准）\n2026-08-01\n（入样启动）'),
|
||
('M-06', 'A-08\n更换 QA 负\n责人，优化\n质量团队',
|
||
'① 即日起免除 QA 负责人左胜职务，由毕海临时代管 QA 事务\n'
|
||
'② 毕海组织面试不少于 20 名 QA 候选人（林毅/董方辅助推荐）\n'
|
||
'③ 优先从具备酶行业知识的研发骨干中培养，要求懂酶 + 懂法规\n'
|
||
'④ 确定新 QA 负责人后，明确其职责边界（对接客户、向研发/生产提需求）\n'
|
||
'⑤ 加强 QA/QC 人员的持续培训与考核机制',
|
||
'毕海（牵头）\n任宏杰（配合）', '面试启动：即日\n2026-06-01\n（到岗目标）'),
|
||
('M-07', 'A-09\n补齐关键\n设备',
|
||
'① 二袁对接采购：灭菌锅、干燥箱、砝码、设备标识\n'
|
||
'② 研发部荧光仪优先调配至生产端用于 RI 活性检测\n'
|
||
'③ 所有设备需完成校准/验证后方可投入使用',
|
||
'二袁（采购）\n任宏杰（设备调配）', '2026-05-31'),
|
||
('M-08', 'A-10\n酶与 buffer\n分离管理',
|
||
'① 将酶与 buffer 分开存储、分开建立质量标准\n'
|
||
'② 分别开展稳定性研究（纳入 A-07 统筹）\n'
|
||
'③ 修订相关 SOP 和批记录模板',
|
||
'新 QA 负责人\n生产部', '2026-06-30'),
|
||
]
|
||
|
||
ma_header = [
|
||
Paragraph('关联\n缺陷', S['cell_header']),
|
||
Paragraph('行动项', S['cell_header']),
|
||
Paragraph('具体措施', S['cell_header']),
|
||
Paragraph('责任人', S['cell_header']),
|
||
Paragraph('预估完成\n日期', S['cell_header']),
|
||
]
|
||
ma_data = [ma_header]
|
||
for defect, action, measures, owner, date in maj_actions:
|
||
ma_data.append([
|
||
Paragraph(f'<b>{defect}</b>', S['cell_maj']),
|
||
Paragraph(action, S['cell_bold']),
|
||
Paragraph(measures, S['cell']),
|
||
Paragraph(owner, S['cell_bold']),
|
||
Paragraph(date, S['cell_bold']),
|
||
])
|
||
ma_t = Table(ma_data, colWidths=[1.5*cm, 2.2*cm, 8.3*cm, 2.5*cm, 3.0*cm])
|
||
ma_t.setStyle(TableStyle([
|
||
('BACKGROUND', (0,0), (-1,0), ORANGE_MAJ),
|
||
('TEXTCOLOR', (0,0), (-1,0), WHITE),
|
||
('FONTNAME', (0,0), (-1,0), 'STHeiti'),
|
||
('ROWBACKGROUNDS', (0,1), (-1,-1), [BG_MAJ, WHITE]),
|
||
('GRID', (0,0), (-1,-1), 0.4, GRAY_LINE),
|
||
('TOPPADDING', (0,0), (-1,-1), 4),
|
||
('BOTTOMPADDING', (0,0), (-1,-1), 4),
|
||
('LEFTPADDING', (0,0), (-1,-1), 5),
|
||
('RIGHTPADDING', (0,0), (-1,-1), 5),
|
||
('VALIGN', (0,0), (-1,-1), 'TOP'),
|
||
]))
|
||
story.append(ma_t)
|
||
story.append(Spacer(1, 0.35*cm))
|
||
|
||
# ── 4.3 一般缺陷行动项 ────────────────────────────────────────────────────
|
||
story.append(Paragraph('4.3 一般缺陷整改行动项', S['subsection']))
|
||
|
||
min_actions = [
|
||
('N-01', 'A-11\n现场卫生\n整改',
|
||
'① 即日安排人员清理下水管道锈蚀，必要时更换管道\n② 建立日常现场卫生检查制度（每日巡检记录）',
|
||
'生产部\n毕海（督导）', '2026-05-15'),
|
||
('N-02', 'A-12\n消除文件\n低级错误',
|
||
'① 系统排查现有文件中的替换页、纸张颜色不一致问题，统一重印\n② 制定文件印制和替换标准操作程序',
|
||
'新 QA 负责人', '2026-06-30'),
|
||
('N-03', 'A-13\n完善批记\n录数据项',
|
||
'① 修订批记录模板，新增计算过程记录栏\n② 对现有操作人员开展批记录填写规范培训',
|
||
'新 QA 负责人\n生产部', '2026-06-30'),
|
||
]
|
||
|
||
mi_header = [
|
||
Paragraph('关联\n缺陷', S['cell_header']),
|
||
Paragraph('行动项', S['cell_header']),
|
||
Paragraph('具体措施', S['cell_header']),
|
||
Paragraph('责任人', S['cell_header']),
|
||
Paragraph('预估完成\n日期', S['cell_header']),
|
||
]
|
||
mi_data = [mi_header]
|
||
for defect, action, measures, owner, date in min_actions:
|
||
mi_data.append([
|
||
Paragraph(f'<b>{defect}</b>', S['cell_min']),
|
||
Paragraph(action, S['cell_bold']),
|
||
Paragraph(measures, S['cell']),
|
||
Paragraph(owner, S['cell_bold']),
|
||
Paragraph(date, S['cell_bold']),
|
||
])
|
||
mi_t = Table(mi_data, colWidths=[1.5*cm, 2.2*cm, 8.3*cm, 2.5*cm, 3.0*cm])
|
||
mi_t.setStyle(TableStyle([
|
||
('BACKGROUND', (0,0), (-1,0), colors.HexColor('#9B7D11')),
|
||
('TEXTCOLOR', (0,0), (-1,0), WHITE),
|
||
('FONTNAME', (0,0), (-1,0), 'STHeiti'),
|
||
('ROWBACKGROUNDS', (0,1), (-1,-1), [BG_MIN, WHITE]),
|
||
('GRID', (0,0), (-1,-1), 0.4, GRAY_LINE),
|
||
('TOPPADDING', (0,0), (-1,-1), 4),
|
||
('BOTTOMPADDING', (0,0), (-1,-1), 4),
|
||
('LEFTPADDING', (0,0), (-1,-1), 5),
|
||
('RIGHTPADDING', (0,0), (-1,-1), 5),
|
||
('VALIGN', (0,0), (-1,-1), 'TOP'),
|
||
]))
|
||
story.append(mi_t)
|
||
story.append(Spacer(1, 0.5*cm))
|
||
|
||
# ═══════════════════════════════════════════════════════════════════════════
|
||
# 五、整改里程碑时间轴汇总
|
||
# ═══════════════════════════════════════════════════════════════════════════
|
||
story.append(section_header('五、整改里程碑时间轴汇总'))
|
||
story.append(Spacer(1, 0.2*cm))
|
||
|
||
timeline_header = [
|
||
Paragraph('里程碑节点', S['cell_header']),
|
||
Paragraph('主要行动项', S['cell_header']),
|
||
Paragraph('责任人', S['cell_header']),
|
||
Paragraph('目标日期', S['cell_header']),
|
||
]
|
||
timeline_data = [timeline_header,
|
||
[Paragraph('★ 立即启动\n（≤ 1 周）', S['cell_crit']),
|
||
Paragraph('A-01 发布数据诚信禁令；A-08 免除左胜职务、毕海代管QA；A-09 研发设备调配至生产；A-11 现场清洁启动', S['cell']),
|
||
Paragraph('毕海、任宏杰、二袁', S['cell_bold']),
|
||
Paragraph('2026-04-22', S['cell_bold'])],
|
||
[Paragraph('第一阶段\n（1个月内）', S['cell_crit']),
|
||
Paragraph('A-01 数据诚信制度落地；A-08 启动QA招聘（面试≥20人）；A-09 设备采购启动；A-11 现场卫生完成', S['cell']),
|
||
Paragraph('毕海（主）\n二袁（采购）', S['cell_bold']),
|
||
Paragraph('2026-05-15', S['cell_bold'])],
|
||
[Paragraph('第二阶段\n（2个月内）', S['cell_maj']),
|
||
Paragraph('A-02 RI临时检测方案上线；A-05 偏差/OOS/OOT程序建立；A-08 新QA负责人到岗；A-03 清洁验证主计划发布', S['cell']),
|
||
Paragraph('新QA负责人\n任宏杰', S['cell_bold']),
|
||
Paragraph('2026-06-15', S['cell_bold'])],
|
||
[Paragraph('第三阶段\n（3个月内）', S['cell_maj']),
|
||
Paragraph('A-04 文件体系重建完成；A-06 工艺验证报告补充完成；A-07 稳定性研究入样启动；A-10 酶/buffer分离管理完成；A-12/13 批记录规范化', S['cell']),
|
||
Paragraph('新QA负责人\n任宏杰\n生产部', S['cell_bold']),
|
||
Paragraph('2026-06-30', S['cell_bold'])],
|
||
[Paragraph('第四阶段\n（4~5个月内）', S['cell_maj']),
|
||
Paragraph('A-02 RI活性正式纳入质量标准并完成方法验证；A-06 3批次工艺验证完成；A-09 正式设备到位并完成验证', S['cell']),
|
||
Paragraph('任宏杰\n新QA负责人', S['cell_bold']),
|
||
Paragraph('2026-07-31', S['cell_bold'])],
|
||
[Paragraph('第五阶段\n（≤6个月）', S['cell_bold']),
|
||
Paragraph('A-03 清洁验证关键品种完成；A-02 RI活性检测体系完全建立；准备接受申基/客户复查审计', S['cell']),
|
||
Paragraph('毕海\n新QA负责人\n全员', S['cell_bold']),
|
||
Paragraph('2026-08-31', S['cell_bold'])],
|
||
]
|
||
tl_t = Table(timeline_data, colWidths=[2.8*cm, 9.2*cm, 2.8*cm, 2.7*cm])
|
||
tl_t.setStyle(TableStyle([
|
||
('BACKGROUND', (0,0), (-1,0), DARK_BLUE),
|
||
('TEXTCOLOR', (0,0), (-1,0), WHITE),
|
||
('FONTNAME', (0,0), (-1,0), 'STHeiti'),
|
||
('ROWBACKGROUNDS', (0,1), (-1,-1), [BG_CRIT, BG_CRIT, BG_MAJ, BG_MAJ, BG_MAJ, LIGHT_BLUE]),
|
||
('GRID', (0,0), (-1,-1), 0.4, GRAY_LINE),
|
||
('TOPPADDING', (0,0), (-1,-1), 5),
|
||
('BOTTOMPADDING', (0,0), (-1,-1), 5),
|
||
('LEFTPADDING', (0,0), (-1,-1), 6),
|
||
('RIGHTPADDING', (0,0), (-1,-1), 6),
|
||
('VALIGN', (0,0), (-1,-1), 'TOP'),
|
||
]))
|
||
story.append(tl_t)
|
||
story.append(Spacer(1, 0.5*cm))
|
||
|
||
# ═══════════════════════════════════════════════════════════════════════════
|
||
# 六、决议与签字
|
||
# ═══════════════════════════════════════════════════════════════════════════
|
||
story.append(section_header('六、会议决议与签署'))
|
||
story.append(Spacer(1, 0.2*cm))
|
||
|
||
decisions = [
|
||
'本次会议就申基供应商审计发现的全部问题达成整改共识，与会人员承诺按照上述行动计划推进落实。',
|
||
'4000 万元订单执行不受本次审计直接影响，各方共担下游药企提考连带责任，应以主人翁心态推进整改。',
|
||
'整改优先级排序：RI 活性检测体系建立 → 数据诚信管理 → 清洁验证 → QA 人员优化 → 文件体系重建 → 稳定性研究。',
|
||
'所有整改措施的完成情况须由新任 QA 负责人进行验证和记录，整改完成后须准备向申基/客户提交整改报告并接受复查审计。',
|
||
'毕海为本次整改的首要协调人，任宏杰负责研发端支持，二袁负责客户沟通与采购事务。',
|
||
]
|
||
for i, d in enumerate(decisions, 1):
|
||
story.append(Paragraph(f'{i}. {d}', S['body']))
|
||
story.append(Spacer(1, 0.5*cm))
|
||
|
||
sign_data = [
|
||
[Paragraph('主持人', S['cell_bold']),
|
||
Paragraph('任宏杰 签名：_______________', S['cell']),
|
||
Paragraph('日期：_____________', S['cell'])],
|
||
[Paragraph('质量代表', S['cell_bold']),
|
||
Paragraph('毕海 签名：_______________', S['cell']),
|
||
Paragraph('日期：_____________', S['cell'])],
|
||
[Paragraph('商务/对外', S['cell_bold']),
|
||
Paragraph('二袁 签名：_______________', S['cell']),
|
||
Paragraph('日期：_____________', S['cell'])],
|
||
[Paragraph('参会确认', S['cell_bold']),
|
||
Paragraph('说话人 C 签名：_______________', S['cell']),
|
||
Paragraph('日期：_____________', S['cell'])],
|
||
[Paragraph('参会确认', S['cell_bold']),
|
||
Paragraph('说话人 E 签名：_______________', S['cell']),
|
||
Paragraph('日期：_____________', S['cell'])],
|
||
]
|
||
sign_t = Table(sign_data, colWidths=[2.8*cm, 9*cm, 5.7*cm])
|
||
sign_t.setStyle(TableStyle([
|
||
('BACKGROUND', (0,0), (0,-1), BG_HEAD),
|
||
('GRID', (0,0), (-1,-1), 0.4, GRAY_LINE),
|
||
('TOPPADDING', (0,0), (-1,-1), 8),
|
||
('BOTTOMPADDING', (0,0), (-1,-1), 8),
|
||
('LEFTPADDING', (0,0), (-1,-1), 6),
|
||
('RIGHTPADDING', (0,0), (-1,-1), 6),
|
||
('VALIGN', (0,0), (-1,-1), 'MIDDLE'),
|
||
]))
|
||
story.append(sign_t)
|
||
story.append(Spacer(1, 0.4*cm))
|
||
|
||
# ── 页脚说明 ──────────────────────────────────────────────────────────────
|
||
story.append(HRFlowable(width=W, thickness=0.5, color=GRAY_LINE))
|
||
story.append(Spacer(1, 0.1*cm))
|
||
story.append(Paragraph(
|
||
'本文件为愚公生物科技有限公司（百时美）内部保密文件，未经授权不得对外披露。\n'
|
||
'文件编号：YG-QA-MOM-2026-001 版本：V1.0 生效日期：2026-04-15 制定部门：质量管理部',
|
||
S['footer']))
|
||
|
||
doc.build(story)
|
||
print(f'PDF generated: {output_path}')
|
||
|
||
if __name__ == '__main__':
|
||
output = '/Users/tankai/Documents/Projects/deep_research/愚公生物_申基审计整改会议纪要_2026-04-10.pdf'
|
||
build_pdf(output)
|