APIC 发布通用质量问卷 version 1，用于原料药供应商质量调查
General Quality Questionnaire
APIC 发布通用质量问卷 version 1，共 11 页，是面向原料药供应商的质量调查问卷模板，官方目录发布日为 2026-10-13。
问卷按人员、质量体系文件、数据完整性、变更与偏差等章节列出供应商核查项，可用于比对原料药供应商质量体系的覆盖范围。
APIC 技術出版物：General Quality Questionnaire
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
General Quality Questionnaire – version 1 Page 1 of 11
A. General Information
1. Company Information
1.1 Company Address Information
Name of company:
Address, Postcode:
Country:
1.2 Address Information of Site of Interest
Name of company (if different from
above):
Address, Postcode:
Country:
1.3 Contact Information (Please provide details of an available contact)
Name:
Position:
Telephone number:
Email address:
1.4 Nature of operations (check all that apply)
Manufacturing of materials supplied Yes No
Trading of materials supplied Yes No
If you do trading of materials, please add
name & address of manufacturer:
Service provider Yes
If you are a service provider, please
specifiy which service (s):
第 2 页
Supplier Quality Questionnaire
General Quality Questionnaire – version 1 Page 2 of 11
2. Personnel
2.1 PERSONNEL - ORGANISATION
2.1.1 Please enclose a copy of your high-level organisational chart indicating key
Enclosed Ref: N/A
personnel.
2.1.2 Total number of personnel at the site of interest (as referenced in 1.2): FTE
2.1.3 Number of employees in:
• Management: FTE
• Operations: FTE
• Quality Assurance (QA): FTE
• Quality Control (QC): FTE
• R&D: FTE
• Maintenance: FTE
• Warehouse (if applicable): FTE
2.1.4 Are the responsibilities and tasks of all personnel defined in written job
Yes No
descriptions?
2.1.5 Is the Quality Unit independent from Operations? Yes No
2.1.6 Which department approves product release (if applicable)?
2.2 PERSONNEL – TRAINING
2.2.1 Is a written procedure for training of employees in place? Yes No
2.2.2 Are job-specific training requirements clearly defined? Yes No
2.2.3 Are training effectiveness and employee competency periodically assessed? Yes No
2.2.4 Is GMP training conducted on a regular basis and in sufficient frequency to assure
Yes No N/A
that the employees remain familiar with current GMP requirements?
2.2.5 Is all training documented? Yes No
COMMENTS:
第 3 页
Supplier Quality Questionnaire
General Quality Questionnaire – version 1 Page 3 of 11
3. Main Activities
3.1 Please describe the company’s field of operation, indicating the approximate
proportion of business (in %) related to the following industry sectors:
Pharmaceutical Industry (incl. Active Pharmaceutical Ingredient (API) producers):
%
Food Industry: %
Other Industries: %, please specify which:
3.2 Does your company handle any of the following compounds at the site / those sites
where products for us (specified in section 4) are handled?
Penicillins, Cephalosporins, Cephamycins, Infectious materials, DNS-Alkylating agents Yes No
(e.g. Cytostatics, Cytotoxics or Antineoplastics), Steroids, Hormones, Biological
preparations, e.g. from live micro-organisms, Herbicides, Pesticides or Fungicides
3.3 Have you been audited by any Pharmaceutical / API manufacturing companies
Yes No
within the last two years?
COMMENTS:
4. Products or Services in scope of the collaboration
Material name / Description of service
If required, please add list of all materials as appendix
第 4 页
Supplier Quality Questionnaire
General Quality Questionnaire – version 1 Page 4 of 11
5. Quality Standards and Certifications
5.1 Does your company have a quality management system in place Yes No
5.2 Do you hold certification(s) against any recognized quality standards by an
accredited third-party body e.g. cGMP, ISO 9001, 14001 or 22000? Yes No
If yes: specify and provide copies of certificates:
Ref.:
5.3 Do you hold licences/registrations issued by any regulatory agency or body? Yes No N/A
If yes specify and provide copies:
Ref.:
5.4 Has the company been subject to periodic audits by competent health authorities
(e.g. EMA, MHRA, FDA...) or notified inspection bodies (ISO, etc...)? Yes No N/A
If yes, please provide details of the latest inspection date(s):
Authority Date
5.5 If the answer to question 5.3 is yes, are there – at the time of completion of this
questionnaire – any pending (unresolved) critical observations / warning letters Yes No N/A
resulting from these inspections?
5.6 Are any aspects of the manufacturing process or of the service provided
Yes No N/A
subcontracted?
If so, please provide detail:
5.7 Are there Quality / Technical / Service Level Agreements held with these
Yes No N/A
subcontractors?
COMMENTS:
第 5 页
Supplier Quality Questionnaire
General Quality Questionnaire – version 1 Page 5 of 11
6. Quality Management Documentation
Do you have procedures that document how you perform the following activities:
If ‘YES’ please provide the document reference number / identification.
6.1 QUALITY SYSTEM Comment
6.1.1 Quality Policy / Manual Yes No N/A
6.1.3 Internal Audit / Self-Inspection Program Yes No N/A
6.1.4 Supplier Evaluation / Qualification Program Yes No N/A
6.1.6 Training Program Yes No N/A
6.1.7 Change Control Yes No N/A
6.1.8 Deviation / Investigation Reporting Yes No N/A
6.1.9 Non-Conformance Reporting Yes No N/A
6.1.10 Documentation Control Yes No N/A
6.1.11 Do you have a recall system/procedure in place? Yes No N/A
6.2 FACILITIES AND EQUIPMENT SYSTEM
6.2.1 Pest Control Program Yes No N/A
6.2.2 Preventive Maintenance Program Yes No N/A
6.2.3 Calibration Program Yes No N/A
6.2.3 Equipment & Instrument Qualification Yes No N/A
6.2.4 Facility Cleaning / Sanitization Yes No N/A
7. SOP System / Document Control
7.1 Are written procedures (SOPs) established for all quality related activities? Yes No
7.2 Are quality-related procedures approved by the Quality Unit? Yes No
7.3 Do you perform a periodic review of SOPs? Yes No
7.4 Are the issuance and distribution of SOPs controlled? Yes No
7.5 Is a system in place to assure that obsolete versions of quality relevant documents
Yes No
are withdrawn from use?
COMMENTS:
第 6 页
Supplier Quality Questionnaire
General Quality Questionnaire – version 1 Page 6 of 11
8. Data Management and Data Integrity
8.1 Optional sub-headline
8.1.1 Is there a documented policy ensuring the integrity of data and its management
Yes No
within your organization?
8.1.2 If the answer to 8.1.1 is yes, do you hold official certificates on these topics (e.g. Yes No N/A
ISO27001) ?
If so, which ones?
8.1.3 Do you have documented evidence (e. g. training records) showing that each staff Yes No
member generating or manipulating critical data has been trained regarding the
principles of Data Integrity?
8.1.4 Do you have written procedures describing how and how long quality relevant data Yes No N/A
will be kept in archives before disposal (destruction)?
If yes, what is your archiving period…:
… for paper data?
… for electronic data?
8.1.5 Are your quality critical electronic systems protected against unauthorized access? Yes No N/A
8.1.6 Are your quality critical electronic systems subject to regular backup? Yes No N/A
8.1.7 Do you have specific procedures dealing with cyber security? Yes No
8.1.8 If the answer to 8.1.7 is yes, do you hold any official certificates on this topic? Yes No N/A
If so, which ones?
COMMENTS:
第 7 页
Supplier Quality Questionnaire
General Quality Questionnaire – version 1 Page 7 of 11
9. Change Management
9.1 Is a written procedure/system for change control in place? Yes No
9.2 Do you classify changes according to their impact on product quality (e.g. minor and
Yes No N/A
major changes)?
9.3 Are changes which have impact on the product quality approved by the Quality Unit? Yes No N/A
9.4 Do you assess (as part of the change request) whether customers need to be
Yes No N/A
informed on major changes affecting product quality?
9.5 Is a log maintained of changes to processes, materials, equipment and methods? Yes No
9.6 Are you notified about changes from your suppliers / sub-contractors? Yes No
COMMENTS:
10. Deviation Handling / OOS Handling
10.1 Is a written procedure/system for the handling of deviations and non-conformances
Yes No
in place?
10.2 Are deviations from established procedures documented, investigated in a timely
Yes No
manner and filed by the Quality Unit?
10.3 Do investigations of deviations consider the impact on product quality or the service
Yes No N/A
delivered?
10.4 Do investigations of deviations consider the impact on product quality of previous
Yes No N/A
batches or previous services being delivered?
10.5 Are the results of investigations reviewed and approved by the Quality Unit? Yes No N/A
10.6 Is a written procedure/system for investigating Out of specification results
Yes No N/A
established?
10.7 Does the OOS SOP comply with concepts / processes as defined in US-FDA OOS or
Yes No N/A
MHRA Guidelines?
COMMENTS:
第 8 页
Supplier Quality Questionnaire
General Quality Questionnaire – version 1 Page 8 of 11
11. Complaints / Recalls
11.1 Are complaints recorded and investigated according to a written procedure? Yes No
11.2 What is your time target for responding to complaints?
11.3 Do you have a written procedure in place which defines the circumstances under
Yes No N/A
which a recall or market withdrawal of a product should be considered?
COMMENTS:
12. Sub-contractor Qualification
12.1 Do you work with sub-contractors? Yes No
12.2 Is there a written contract in place between the sub-contractor and your company
Yes No N/A
where all tasks, services and responsibilities are clearly defined?
12.3 Is a written procedure for sub-contractor qualification in place? Yes No N/A
12.4 Is the sub-contractor qualification documented? Yes No N/A
12.5 Do you carry out periodical monitoring of sub-contractors? Yes No N/A
12.6 Does the procedure on sub -contractor qualification consider a re-qualification? Yes No N/A
If yes, what is your re-qualification period?
12.7 Is ensured that you only use / order from approved sub-contractors? Yes No N/A
12.8 Is a system in place to assure that your sub-contractors notify you about significant
Yes No N/A
changes?
12.9 Are written specifications / quality requirements clearly defined for the products /
Yes No N/A
services delivered from your sub-contractor?
12.10 Is a system in place to assure that only current versions of specifications/quality
Yes No N/A
requirements are used?
COMMENTS:
第 9 页
Supplier Quality Questionnaire
General Quality Questionnaire – version 1 Page 9 of 11
13. Internal Audits
13.1 Do you perform internal audits on a regular base? Yes No
13.2 Are internal audits performed by the Quality Unit? Yes No N/A
13.3 Are audit findings documented? Yes No N/A
13.4 Are corrective actions defined and implemented in a timely manner? Yes No N/A
COMMENTS:
14. Business Continuity
14.1 Is a business continuity plan established? If yes, please answer the following
Yes No
questions:
14.2 What elements are covered by your business continuity plan:
• Purchasing/Supplier
• Supply chain Yes No
• Production Yes No
• Facilities / Utilities Yes No
• Quality (e.g. Back up of equipment) Yes No
• SHE Yes No
• Human Resources Yes No
• IT Yes No
• Finance Yes No
• Natural disaster (e.g. flooding, earthquake) Yes No
Yes No
• Pandemics
Yes No
Please refer the document ID(s) here: _______________________
COMMENTS:
第 10 页
Supplier Quality Questionnaire
General Quality Questionnaire – version 1 Page 10 of 11
15. Comments, References, Appendices
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
第 11 页
Supplier Quality Questionnaire
General Quality Questionnaire – version 1 Page 11 of 11
Completion Signatures
▪ Confirmation that enclosed information is correct and relevant to the product(s) in scope.
▪ You will inform us in case of any changes to the product status
Completed by:
Name (Print):
Position:
Signature:
Date:
Approved by (name of Quality representative):
Name (Print):
Position:
Signature:
Date:
来源：APIC 原料药质量技术文件 · apic.cefic.org