APIC 发布第三方审计服务商调查问卷
Questionnaire for Service provider 3rd Party Audit
APIC 于 2026-10-13 在其官方目录发布第三方审计服务商调查问卷，用于收集服务商可提供的审计标准、审计类型及年度审计数量等信息。问卷共 5 页，涵盖服务管理、审计员资质与再培训、审计执行，并询问审计反馈、审计报告和CAPA计划评估的时限。该文件为 APIC 技术资料，需由服务商填写并由现场运营负责人和质量负责人签署确认，不属于监管机关发布的法规。
问卷列出第三方审计服务商在审计标准、审计员资质、审计执行与CAPA时限方面的核查项，可供供应商审计时对照使用。
APIC 技術出版物：Questionnaire for Service provider 3rd Party Audit
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。
第 1 页
Supplier Quality Questionnaire
Questionnaire Service Provider Third party audit Page 1 of 5
19. Detailed questionnaire for Third Party Audit
1. Third Party Audit Details
1.1 Company Address Information
Name of company:
Address:
Postcode:
Country:
Website:
1.2 Contact Information (Please provide details of an available contact)
This information should be filled into the General Questionnaire.
Commenté [VD1]: add to each paragraph a line for comments
2. General information
Commenté [RT2R1]: That is already there, right?
2.1 Information about provided services
2.1.1 What are the auditing standards that you are able to offer to your customers? GMP – API Commenté [VD3]: add excepients standards
Commenté [HG4R3]: IPEC
GMP – Finished Product
GDP
GLP
ISO 9001
IPEC
Other (please in
"comments")
2.1.2 What are the audit types that you are able to perform? Physical audit
Remote audit
2.1.3 How many audits does your company perform on a yearly basis?
2.1.4 How many audits will you be able to perform on the behalf of our company on a
yearly basis?
COMMENTS:
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2.2 Service Management
2.2.1 What are the geographical areas covered by your company?
2.2.2 In which geographical area your auditors located?
2.2.3 Is the qualified auditor systematically native of the country in which the audit has to
Yes No
be performed?
2.2.4 If no, for which countries do you apply native auditors systematically?
2.2.5 The auditing service includes:
• Exclusive audits for one customer only
• Audits combining requests for multiple customers Yes No
• Selling existing audit reports
• Other (please specify)
2.2.6 Is confidentiality assured in case of audits covering multiple customers? Yes No
COMMENTS:
3. Auditor Management
3.1 Auditor information
3.1.1 Are the auditors' employees of your company or do you work with freelance Own employees
auditors?
Freelance auditors
3.1.2 In case you work with freelance auditors, do contracts include clauses covering… Confidentiality?
Conflict of interest?
3.1 Auditor qualification
3.2.1 Do you share auditors CV with customer prior to the audit performance? Yes No Commenté [RT5]: 3. Auditor Qualification & Competence
Auditor Selection
Describe the criteria for auditor qualification:
3.2.2 Please specify your minimum requirements for qualification of auditors: Minimum experience required:
Relevant education requirements:
Training Program
Is there an initial training program? ☐ Yes ☐ No
Is continuous training performed? ☐ Yes ☐ No
Frequency of requalification:
Expertise
3.2.3 Do you offer regular auditor (re-)training on the auditing standards referred in 2.1.1? Yes No Expertise areas available:
☐ Sterile manufacturing
3.2.4 If yes, what is the frequency? Please specify. ☐ APIs (chemical)
☐ Biotech/biologics
☐ Packaging/labelling
3.2.5 In general, how many audits does an auditor perform on a yearly basis? Provide CVs of key auditors (upon reques
3.2.6 How do you avoid a potential conflict of interest of the selected auditor(s)? Commenté [HG6R5]: Agreed in meeting of 24.08.2026: We
leave the open question 3.2.2, do not specify potential details or
minimum requirements.
3.2.7 How do you maintain consistency among auditors?
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COMMENTS:
4. Audit execution
4.1 Audit documents
4.1.1 Do you have templates for audit documentation? Yes No
4.1.2 If yes, for what documents? Audit agenda Commenté [HG7]: GEROLD: Add tickboxes
Please provide the document template(s) in attachment of this questionnaire. Preliminary audit
summary
Audit summary
Audit report
CAPA plan evaluation
CAPA plan follow-up
4.1.3 If yes, are you willing to customize your standard templates for reporting? Yes No Commenté [HG8]: GEROLD: Add yes/ no and correct
numbering
4.1.4 What is the deadline after audit execution to provide initial audit feedback to
customer (in days)?
4.1.5 What is the deadline after audit execution to provide the audit report, to customer
(in days)?
4.1.6 How much time do time do you allow the audited company to provide a CAPA plan
(in days)
4.1.7 What is the deadline after CAPA plan receipt to provide the CAPA plan evaluation to
customer (in days)?
COMMENTS:
4.2 Audit findings information
4.2.1 Do you have a standard evaluation table to classify (e.g. major, minor,
recommendation) the audit findings? Yes No
If yes, please share this information in attachment of the questionnaire
4.2.2 Are the auditor findings peer reviewed internally to ensure appropriate
Yes No
classification?
4.2.3 Do you have a specific process to follow in case of critical finding(s) are detected
Yes No
during an audit? If yes, please explain in "comments".
4.2.4 Does your service include CAPA plan evaluation and follow up until audit closure? Yes No
COMMENTS:
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3. Comments
Please list all references and enclosures that you make to this questionnaire and specify the reference number given to
each document. Use one list for all sections of the document and extend it if needed.
Ref # Description / Name
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Completion Signatures
▪ Confirmation that enclosed information is correct and relevant to the product(s) in scope.
▪ Confirmation that you will inform us in case of any changes to the product status
Site Operations Lead Representative:
Name (Print):
Position:
Signature:
Date:
Head of Quality Assurance or representative; person who completed the questionnaire:
Name (Print):
Position:
Signature:
Date:
来源：APIC 原料药质量技术文件 · apic.cefic.org