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APIC 原料药质量技术文件·· 15 小时前AI 评分55

APIC 发布供应商问卷封面页及填写说明 Version 01

Questionnaire Cover sheet and instructions

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APIC 发布供应商问卷封面页及填写说明 Version 01,官方目录发布日为 2026-10-13,声明该文件不是监管机关发布的法规。问卷须由公司代表填写,并由生产或供应场地的质量保证部门批准,通用问卷 A、B 部分对所有供应商或服务商均为必填,专用问卷按所供物料或服务类型选取,C、D 部分分别针对关键原料生产商及其贸易商。

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APIC 技術出版物:Questionnaire Cover sheet and instructions

官方目錄發布日:2026-10-13(原文 13/10/2026,DD/MM/YYYY);文件版本或修訂日期另見正文。

本文為 APIC 技術資料,不是監管機關發布的法規。

PDF 文字版;图形和原始排版请参阅官方 PDF。

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SUPPLIER QUESTIONNAIRES – Cover Sheet and Instructions for Completion
                                                                                                            Version 01
IMPORTANT: PLEASE READ THE INSTRUCTIONS BELOW BEFORE COMPLETING THE ENCLOSED QUESTIONNAIRES
   These questionnaires should be completed by a representative of the company and approved by the
    company's Quality Assurance (or equivalent) department from the site of manufacture/supply. It is not to be
    completed by a representative from the marketing facility or general headquarters.
   Please take the time to fill out these questionnaires with as much detail as possible. The information will
    facilitate the evaluation and potential approval/qualification of your company as a supplier.
   Please answer all questions (if a question is not applicable, please mark as N/A).
   The general questionnaires (section A and B) are mandatory for every supplier / service provider. The more
    specific questionnaires are selected below, if required.
   If additional space or evidence (e.g. ISO certificates) is needed to fully complete any section of this
    evaluation, please attach this additional information or evidence, as applicable, and list in the reference list.
   If you are a broker/trader/distributor or agent selling product(s) manufactured by other companies, please
    provide the filled questionnaires indicated below for each of the manufacturing companies supplying
    products.

Required Questionnaires (as indicated by checked box(es)):
(Please complete the following applicable Questionnaires based on the type of the supplied material or service)
        Section A: General Quality Questionnaire
        Section B: Corporate, Social and Responsible Care Questionnaire*
        Section C: Questionnaire for Manufacturers of Critical Raw Materials
        Section D: Questionnaire for Traders (Distributor/Broker/Agent) of Critical Raw Materials
        Section E: Questionnaire for Engineering Service Providers*
        Section F: Questionnaire for Laboratory Service Providers*
        Section G: Questionnaire for IT Service Providers*
        Section H: Questionnaire for Pest Control Service Providers*
        Section I: Questionnaire for Distribution and Warehousing Service Providers*
        Section J: Questionnaire for 3rd Party Auditing Service Providers*


At the time of publication of this Cover Sheet, Questionnaires marked with an * are not published yet.


Completed questionnaires to be
returned to:

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References for the Supplier Questionnaires
The APIC Supplier Management Guide explains background and purpose of these questionnaires.
You can find the document on the APIC website:
https://apic.cefic.org/publication/best-practices-guide-for-managing-suppliers-of-api-manufacturers/

The Structure of Questionnaires
This set of questionnaires is structured as follows:




The top-level document is this "Cover Sheet and Instructions".
The General Questionnaires need to be filled out by every supplier or service provider.
The Specific Questionnaires that need to be filled have been selected according to the product or
service you are providing.




Version History
01            Initial release
               with reference to questionnaires which are not published yet (B, E-J).

来源:APIC 原料药质量技术文件 · apic.cefic.org