UNIBEST INDUSTRIAL CO., LTD.
Pharmaceutical Excipient Document Pack — Sep 2026 edition
优贝斯特实业有限公司 · 药用辅料资料包（2026 年 9 月版）

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WHAT IS IN THIS ARCHIVE / 压缩包内容
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00_Document_Pack_Index_EN-CN.pdf ....... Master index 总索引
01_Quality_System_EN-CN.pdf ............ Quality system & GMP certificates 质量体系与 GMP 证书
02_Safety_Statements_EN-CN.pdf ......... BSE/TSE, residual solvents, melamine, allergens 安全性声明
03_Impurity_Control_EN-CN.pdf .......... Elemental impurities, nitrosamines 杂质控制
04_Product_Specifications_EN-CN.pdf .... Specification tables 质量标准
05_Analytical_Methods_EN-CN.pdf ........ Analytical method summary 分析方法
06_CoA_Template_EN-CN.pdf .............. Certificate of analysis template CoA 模板
07_Batch_Consistency_Stability_EN-CN.pdf  Batch & stability data 批间一致性与稳定性
08_Regulatory_Compendial_EN-CN.pdf ..... DMF status, compendial compliance 法规与药典符合性
09_Regional_Declarations_EN-CN.pdf ..... GMO-free, Halal, Kosher 区域附加声明
10_TDS_PEO_EN-CN.pdf ................... PEO technical data sheet PEO 技术数据表
11_TDS_BKC_EN-CN.pdf ................... BKC technical data sheet BKC 技术数据表
12_TDS_Trehalose_EN-CN.pdf ............. Trehalose technical data sheet 海藻糖技术数据表

All documents are bilingual (English / Chinese) and A4 print-ready.
所有文件均为中英双语，A4 可直接打印。

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IMPORTANT — CURRENT STATUS / 重要说明：当前状态
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These files are TEMPLATES. Fields shown as [ to be confirmed ] / [ 待确认 ]
must be completed from the manufacturing site's stamped originals.

本资料包当前为模板版本。标注 [ 待确认 ] 的字段必须由生产场地盖章原件补齐。

Any document that constitutes a declaration, certificate or statement
(BSE/TSE, residual solvents, melamine-free, allergens, elemental impurities,
nitrosamines, DMF, compendial compliance, GMO-free, Halal, Kosher) MUST be
issued and signed by the manufacturing site before it is sent to a customer.

凡属声明、证书或承诺性质的文件（BSE/TSE、残留溶剂、三聚氰胺-free、过敏原、
元素杂质、亚硝胺、DMF、药典符合性、无转基因、Halal、Kosher），必须由生产
场地出具并签章后，方可对外发送。

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HOW TO REPLACE A FILE / 替换流程
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1. Obtain the stamped original from the manufacturing site.
   向工厂索取盖章原件。
2. Save it under the SAME filename in /site/downloads/ — for example
   01_Quality_System_EN-CN.pdf.
   以完全相同的文件名保存在 /site/downloads/ 目录下。
3. Remove the "TEMPLATE / 模板" line in the page footer of the replaced file
   (or rebuild it from the source HTML in /pdfbuild/).
   删除该文件页脚的 “TEMPLATE / 模板” 行（或由 /pdfbuild/ 下的源 HTML 重新生成）。
4. No page links need to change — the website references files by name.
   站内链接无需改动 —— 网站按文件名引用。

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BEFORE SENDING TO A CUSTOMER / 对外发送前的检查清单
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[ ] Every [ to be confirmed ] field completed 所有待确认字段已补齐
[ ] Declarations signed and stamped by the site 声明已由工厂签章
[ ] Certificate validity dates visible 证书有效期可见
[ ] Graded documents match the quoted grade 文件与报价型号一致
[ ] English translation supplied where the original is Chinese 中文原件配英文译本
[ ] Customer confidentiality agreement in place where required 需签署保密协议的已签署

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CONTACT / 联系方式
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Unibest Industrial Co., Ltd.
bd@unibestcn.com  ·  +86 (0)574 2785 5666
11F.1B, Yinchen INTL Mansion, Ningbo, P.R.C.  中国宁波银晨国际大厦 11F.1B

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