APIC 发布关键原料制造商供应商质量问卷第 1 版
Questionnaire for Manufacturers of critical RM
APIC 发布《关键原料制造商问卷》第 1 版，供企业对关键原料供应商的质量体系做书面评估。问卷共 15 页，按质量管理、人员、厂房设施、工艺设备、物料管理、生产、包装标签与质量控制实验室等章节列出是或否问题，官方目录发布日期为 2026-10-13。
问卷按质量管理、设备、物料、制造和实验室等章节列出关键原料供应商评估条目，便于对照核对供应商答复的覆盖范围。
APIC 技術出版物：Questionnaire for Manufacturers of critical RM
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 Quality Questionnaire
Questionnaire for Manufacturers of Critical Raw Materials – version 1 Page 1 of 15
C. Manufacturer Questionnaire
1. Manufacturer Details
1.1 Company Address Information
Name of company:
Site address:
Postcode:
Country:
Website:
1.2 Contact Information (Please provide details of an available contact)
This information should be filled into the General Questionnaire.
1.3 Product Information (List of materials covered by this questionnaire)
Material Name Dedicated equipment
Yes No
Yes No
Yes No
Yes No
Yes No
Yes No
Yes No
Please add list of all materials as appendix if required
1.4 Outsourcing / Third Party Involvement
Are any activities related to manufacturing or testing of the above product(s) outsourced to third
Yes No
parties? If yes, specify below or in a separate annex.
COMMENTS:
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Supplier Quality Questionnaire
Questionnaire for Manufacturers of Critical Raw Materials – version 1 Page 2 of 15
PRELIMINARY COMMENT:
Critical raw materials, including registered starting materials, are generally not subject to GMP
requirements, which typically apply from the first registered intermediate onwards.
However, many suppliers of critical raw materials maintain quality systems and controls that incorporate
principles aligned with, or inspired by, GMP practices. This questionnaire therefore includes not only
questions covering essential requirements for the supply of critical raw materials but also additional
questions intended to assess the implementation of certain GMP practices.
Responses to these questions may be considered as a positive differentiating factor during the evaluation
and selection of suppliers, as they can provide additional confidence in the supplier's ability to
consistently deliver materials of the required quality.
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Questionnaire for Manufacturers of Critical Raw Materials – version 1 Page 3 of 15
2. Quality Management
2.1 QUALITY UNIT - RESPONSIBILITIES
2.1.1 Is/(Are) the Quality Unit(s) independent from Operations? Yes No
Is/(Are) the Quality Unit(s) responsible for:
2.1.2 • Review and approval of all appropriate quality related documents? Yes No
2.1.3 • Review and approval of manufacturing records? Yes No
2.1.4 • Release of material? Yes No
2.1.5 • Review and approval of changes? Yes No
2.1.6 • Approval of (new) suppliers / service providers of quality critical materials
Yes No
and services?
2.1.7 • Performance, documentation and follow-up on Self-Inspections? Yes No
If your answer is "No" on any of the questions above, please explain in the
"Comments" section below:
COMMENTS:
2.2 QUALIFICATION / VERIFICATION / VALIDATION
2.2.1 Is laboratory equipment qualified (with supporting documentation)? Yes No
If the answer is no, is the equipment proven suitable for intended use? Yes No
2.2.2 Is manufacturing equipment qualified (with supporting documentation)? Yes No
If the answer is no, is the equipment proven suitable for intended use? Yes No
2.2.3 Are analytical methods validated (with supporting documentation)? Yes No
If the answer is no, are the analytical methods verified for suitability of intended
Yes No
use?
2.2.4 Are production processes validated (with supporting documentation)? Yes No
If the answer is no, are processes proven to be suitable and consistent? Yes No
COMMENTS:
2.3 REJECTION
2.3.1 Are raw materials, intermediates and products failing to meet established
Yes No
specifications rejected?
2.3.2 Is a procedure for handling of rejected products in place? Yes No
2.3.3 Are rejected materials identified as such and blocked for use? Yes No
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Questionnaire for Manufacturers of Critical Raw Materials – version 1 Page 4 of 15
2.3.4 Is a procedure for reprocessing or reworking of rejected materials in place? Yes No
2.3.5 Is the disposition of rejected material recorded? Yes No
COMMENTS:
2.4 RETURNS
2.4.1 Is a procedure for handling of returned goods in place? Yes No
2.4.2 Are returned products identified as such and labelled accordingly? Yes No
2.4.3 Are returned products stored physically separated? Yes No
2.4.4 Are records of returned goods maintained? Yes No
COMMENTS:
2.5 PRODUCT QUALITY REVIEW (PQR), ANNUAL QUALITY SYSTEM REVIEW (MANAGEMENT REVIEW)
2.5.1 Are regular Product Quality Reviews / Management Reviews conducted? Yes No
If yes, please indicate the frequency:
2.5.2 Do you evaluate / assess Product Quality Reviews whether corrective
Yes No N/A
actions/preventive actions need to be taken?
COMMENTS:
3. Personnel
3.1 PERSONNEL - HYGIENE
3.1.1 Is a written gowning procedure in place to make sure personnel is wearing
appropriate and clean clothing for different activities to protect the personnel as Yes No
well as the product from contamination?
3.1.2 Do you perform personal hygiene training for employees who handle open products
Yes No
as a precaution to prevent contamination of the products and the employees?
COMMENTS:
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Questionnaire for Manufacturers of Critical Raw Materials – version 1 Page 5 of 15
4. Buildings and Facilities
4.1 DESIGN AND CONSTRUCTION
4.1.1 Are written procedures established, followed and documented for cleaning of
Yes No
manufacturing areas, packaging areas, sampling areas and buildings?
4.1.2 Are manufacturing areas and buildings part of the preventive maintenance
Yes No
program?
Are there defined areas for the following activities:
4.1.3 • Receipt of raw materials? Yes No
4.1.4 • Sampling of materials? Yes No
4.1.5 • Quarantine storage before release for raw materials, intermediates and
Yes No
products?
4.1.6 • Storage of released raw materials, intermediates and products? Yes No
4.1.7 • Storage of rejected raw materials, intermediates and products before further
Yes No
disposition (re-processing, return, destruction, …)?
4.1.8 • Manufacturing and processing operations? Yes No
4.1.9 • Packaging and labelling operations? Yes No
4.1.10 • Control and laboratory operations? Yes No
4.1.11 Does the design and construction of the buildings prevent the flow of material and
Yes No
personnel from contamination / mix-up?
COMMENTS:
4.2 UTILITIES
4.2.1 Are all utilities which can impact on product quality (steam, gases, compressed air,
Yes No
ventilation, …) qualified and monitored?
4.2.2 Are there adequate ventilation, air filtration and exhaust systems in place to
Yes No
minimize the risk of cross-contamination?
COMMENTS:
4.3 WATER SYSTEM / WATER QUALITY
4.3.1 Do you have a written specification for process water? Yes No N/A
4.3.2 Does the water quality meet at least the specification on drinking water? Yes No N/A
4.3.3 Is feed water coming into the plant periodically monitored for chemical quality? Yes No N/A
4.3.4 Is feed water coming into the plant periodically monitored for microbial quality? Yes No N/A
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Questionnaire for Manufacturers of Critical Raw Materials – version 1 Page 6 of 15
4.3.5 Is feed water monitoring performed on a regular basis on points of use? Yes No N/A
4.3.6 Is a procedure in place in case the chemical or microbial action limits for process
Yes No N/A
water are exceeded?
4.3.7 Is the treatment to achieve a defined water quality validated and monitored on all
Yes No N/A
points of use?
COMMENTS:
4.4 CONTAINMENT
4.4.1 Are the necessary measures taken to prevent cross-contamination from personnel
Yes No
and materials from one dedicated area to another?
COMMENTS:
4.5 PEST CONTROL
4.5.1 Is a pest control program on the manufacturing site in place? Yes No
4.5.2 Is pest control performed by an external partner? Yes No
4.5.3 Are reports about the pest control program available? Yes No
Are measures taken inside the warehouse(s) (e.g. traps, UV lamps) against:
4.5.4 • Rodents? Yes No
4.5.5 • Flying insects? Yes No
4.5.6 • Crawling insects? Yes No
COMMENTS:
5. Process Equipment
5.1 DESIGN AND CONSTRUCTION
5.1.1 Is production equipment only used within its qualified operating range? Yes No
5.1.2 Is ensured that heating fluids, coolants, … can’t get in contact with the product? Yes No
5.1.3 Are lubricants used which can get in contact with the product? Yes No
5.1.4 If the answer on question 5.1.3 is yes: is it ensured by a statement that they are food
Yes No N/A
grade?
5.1.5 Do you have measures in place to avoid particles caused by equipment failures
Yes No
and/or other abnormal occurrences?
COMMENTS:
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Questionnaire for Manufacturers of Critical Raw Materials – version 1 Page 7 of 15
5.2 EQUIPMENT MAINTENANCE
5.2.1 Do you have a preventive maintenance program in place? Yes No
5.2.2 Are written procedures established and followed for preventive maintenance of
Yes No
equipment?
5.2.3 Are records kept of preventive maintenance, repairs and use? Yes No
COMMENTS:
5.3 CALIBRATION
5.3.1 Are there written procedures for the calibration of quality-critical equipment in
Yes No
place?
5.3.2 Are there a schedule and frequency for re-calibration defined? Yes No
5.3.3 Are limits for accuracy and precision of the equipment defined? Yes No
5.3.4 Are the calibration records maintained? Yes No
5.3.5 Is the calibration status (e.g. date of last and next calibration) indicated on the
Yes No
instruments (e.g. calibration labels)?
5.3.6 Is there a system / procedure specifying that equipment and instruments cannot be
Yes No
used if they are beyond the calibration date?
5.3.7 Are calibration deviations which might have an impact on the product quality
Yes No
investigated?
5.3.8 Is the equipment used calibrated / verified at specific intervals against traceable
Yes No
national or international measurement standards?
5.3.9 Will you provide us with the calibration certificates of the equipment used for the
Yes No
services you deliver to CUSTOMER?
COMMENTS:
5.4 COMPUTERIZED SYSTEMS
5.4.1 Has computer system validation been performed (e.g. according to GAMP 5) for
systems which have an impact on product quality (e.g. system for status Yes No
management)?
5.4.2 Are documents for computer system validation available? Yes No
5.4.3 Are there sufficient controls in place to prevent unauthorized access, changes to
Yes No
data and omissions in data?
5.4.4 Do you record who made a change, when a change was made as well as the previous
Yes No
entry?
5.4.5 Is the entry of critical data additionally checked on accuracy of the entry (by a
Yes No
second operator, the system itself, …)?
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Questionnaire for Manufacturers of Critical Raw Materials – version 1 Page 8 of 15
5.4.6 Are incidents with computerized systems investigated towards a written procedure? Yes No
5.4.7 Are changes to the computerized system made towards a written procedure? Yes No
5.4.8 Do you have a back-up system in place in case of system breakdowns, failures, …? Yes No
COMMENTS:
6. Materials Management
6.1 MATERIAL RECEIPT & SAMPLING/TESTING
6.1.1 Are materials purchased against agreed specifications? Yes No
6.1.2 Do you have a system ensuring that materials are purchased from approved
Yes No
suppliers only?
6.1.3 Are shipping documents compared to the purchasing order? Yes No
6.1.4 Do you perform a visual check on the delivery of materials (labelling, damages,
Yes No
broken seals, …)?
6.1.5 Do you ask for a certificate of analysis for each delivery of material? Yes No
6.1.6 Do you identify each raw material batch with an internal and unique number? Yes No
6.1.7 Are written procedures for sampling and testing of materials in place? Yes No
6.1.8 Is sampling conducted in a defined area to prevent contamination and cross-
Yes No
contamination of the material sampled and contamination of other materials?
6.1.9 Are incoming materials released before they are mixed with existing stocks? Yes No
COMMENTS:
6.2 WAREHOUSE: STORAGE & DISTRIBUTION
6.2.1 Do you use an ERP for warehouse and materials management (e.g. SAP)? Yes No
6.2.2 Are raw materials held under quarantine until they have been tested and released by
Yes No
the Quality Unit?
6.2.3 Are rejected materials identified and controlled under an appropriate system to
Yes No
prevent unauthorised use in manufacturing?
6.2.4 Are raw materials and products handled and stored in a manner to prevent
Yes No
degradation, contamination and cross-contamination?
6.2.5 Do you have scientific evidence (e.g. stability data) to indicate the acceptable storage
Yes No
conditions for your products (e.g. humidity, temperature, protected from light)?
6.2.6 Are temperature and humidity controlled appropriately for the materials stored in
Yes No
the warehouse?
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Questionnaire for Manufacturers of Critical Raw Materials – version 1 Page 9 of 15
6.2.7 Do you monitor the temperature in the storage areas? Yes No
6.2.8 Has a temperature mapping been performed to determine the hottest and coldest
Yes No
spot of the storage area(s)?
6.2.9 Are materials requiring special storage conditions stored accordingly? Yes No
COMMENTS:
6.3 VENDOR QUALIFICATION (SUPPLIER / SUBCONTRACTOR – including Contract Laboratories)
6.3.1 Is a written procedure for vendor qualification in place? Yes No
6.3.2 Does the procedure on vendor qualification consider a re-qualification? Yes No N/A
6.3.3 Is vendor qualification documented? Yes No
6.3.4 Does the vendor qualification consider the primary source (manufacturer) of the
Yes No
product?
6.3.5 Are quality relevant processes outsourced to subcontractors (e.g. contract
Yes No
manufacturer, contract laboratories and technical service provider)?
6.3.6 Is a documented system in place to qualify subcontractors (e.g. contract
Yes No
manufacturer, contract laboratories and technical service provider)?
6.3.7 Is a system in place to assure that your suppliers and subcontractors notify you
Yes No
about significant changes in their processes?
COMMENTS:
7. Manufacturing
7.1 MANUFACTURING DOCUMENTATION
7.1.1 Are written manufacturing instructions in place for each product? Yes No
7.1.2 Is a system in place to assure that only current versions of approved manufacturing
Yes No
instructions are used?
7.1.3 Is the information about which major equipment, instruments, production lines, …
Yes No
have been used during manufacturing included in the batch production records?
7.1.4 Is each product identified with a unique batch or identification number? Yes No
7.1.5 Are critical manufacturing steps witnessed by a second operator? Yes No
7.1.6 Are changes and deviations that occur during the manufacturing process
Yes No
documented in the manufacturing records?
7.1.7 Are critical and major deviations investigated? Yes No
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Questionnaire for Manufacturers of Critical Raw Materials – version 1 Page 10 of 15
7.1.8 Do you have records in place for all your equipment describing its use (or as an
Yes No
alternative is the usage fully traceable)
COMMENTS:
7.2 DESIGN & CONSTRUCTION – CONTAMINATION CONTROL
7.2.1 Are the rooms where final manufacturing steps are performed classified (e.g. ISO 7
Yes No
or ISO 8)?
7.2.2 Is a zone concept with pressure differences for the rooms where final manufacturing
Yes No
steps are performed in place?
7.2.3 Are areas where products are handled or exposed to the production environment,
provided with adequate air filtration, dust collection and exhaust systems to control Yes No
airborne contaminants and prevent cross contamination?
7.2.4 Is the manufacturing equipment designed to minimize the possibility of
Yes No
contamination from the operator (e.g. closed systems)?
7.2.5 Is a written procedure for handling of open products in place to prevent
Yes No
contamination and cross-contamination?
COMMENTS:
7.3 MANUFACTURING EQUIPMENT
7.3.1 Is a system in place to identify major equipment, instruments and production lines
Yes No
(e.g. equipment numbers and labels)?
7.3.2 Are logbooks kept for all major equipment to show which activities have been
Yes No
performed on the equipment (e.g. type of product manufactured)?
COMMENTS:
7.4 MANUFACTURING OPERATIONS
7.4.1 Are raw materials handled (including weighing, measuring, loading, …) appropriately
Yes No
to maintain their identity, quality and purity?
7.4.2 Do you perform reprocessing (repeating process steps that are already part of the
Yes No
regular process)?
7.4.3 Do you perform rework (performing process steps that are not part of the regular
Yes No
process)?
7.4.4 If reprocessing or reworking is performed, is there sufficient investigation,
evaluation and documentation to assure that the final product is at least equivalent
Yes No N/A
to other acceptable product, meeting all established standards, specifications and
characteristics?
7.4.5 If reworking is performed, is the impact on stability, impurities etc. considered and
Yes No N/A
are appropriate controls applied for these issues?
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Questionnaire for Manufacturers of Critical Raw Materials – version 1 Page 11 of 15
7.4.6 Do you use recovered solvents for the products covered by this questionnaire? Yes No N/A
If so, please describe how you do such recoveries:
7.4.7 Is a procedure for blending and mixing of batches in place? Yes No
7.4.8 Are parameters for blending and mixing defined? Yes No
7.4.9 Are individual non-conforming batches blended with others? Yes No
7.4.10 Is the blending and mixing process reproducible to ensure homogeneity of the
Yes No N/A
blended batches?
7.4.11 Does the batch number assigned to the final batch allow traceability back to the
Yes No
individual batches that make up the blend?
COMMENTS:
7.5 EQUIPMENT CLEANING
7.5.1 Is the equipment cleaned at defined intervals (in case of dedicated as well as multi-
Yes No
purpose equipment)?
7.5.2 Are written procedures established where cleaning of equipment is described? Yes No
7.5.3 Is a system in place to assure that only current versions of approved cleaning
Yes No
instructions are used?
7.5.4 Is a system in place for documenting cleaning and the use of equipment (e.g.
Yes No
cleaning records/logbooks and use logbooks)?
7.5.5 Is a system in place to indicate the cleaning status of the equipment (e.g. cleaning
Yes No
label on the equipment)?
7.5.6 Is a system in place to indicate the cleaning status of controlled areas? Yes No
7.5.7 Are acceptance criteria for residues determined to show that cleaning procedures
Yes No N/A
for multi - purpose equipment are adequate to remove the previous materials?
7.5.8 Are cleaning methods validated? Yes No N/A
7.5.9 Is the validation of cleaning methods documented? Yes No N/A
7.5.10 Do you visually verify the cleaning success after a product change over? Yes No
7.5.11 Did you define hardest to clean spots at your manufacturing equipment? Yes No
7.5.12 Do you record the cleaning success of hardest to clean spots? Yes No
COMMENTS:
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Questionnaire for Manufacturers of Critical Raw Materials – version 1 Page 12 of 15
8. Packaging and Labelling
8.1 Are written procedures for labelling and packaging operations in place? Yes No
8.2 Is there a written procedure for clearing the packaging area after each packaging
operation before the next operation, especially if the area is used for packaging of Yes No
different materials à Line clearance?
8.3 Are labels and packaging materials representatively sampled, examined or tested
Yes No
and released before use?
8.4 Are product containers that are shipped outside of the manufacturer's control
Yes No
sealed?
8.5 Are tamper-proof seals used for shipping of finished products? Yes No
Do the shipping labels for finished products contain the following information:
8.6 • name and address of the original manufacturer? Yes No
8.7 • manufacturing and expiration (retest) date? Yes No
8.8 • special storage conditions? Yes No
COMMENTS:
9. Quality Control / Laboratory
9.1 ORGANISATION
9.1.1 Is the Quality Control laboratory internal (at the address specified above)? Yes No
If not, please explain below if it is done at another site / affiliate / 3rd party.
COMMENTS:
9.2 SPECIFICATIONS & RECORDS
9.2.1 Are written specifications and test methods for raw materials, intermediates,
Yes No
packaging materials and finished products in place?
9.2.2 Are all specifications approved by the Quality Unit? Yes No
9.2.3 Is there a system in place to ensure that customer specifications are fulfilled? Yes No
9.2.4 Is a system in place to assure that only current versions of approved specifications
Yes No
are used?
9.2.5 Is a system in place to assure that only current versions of approved testing methods
Yes No
are used?
9.2.6 Are records of all analytical tests available? Yes No
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Questionnaire for Manufacturers of Critical Raw Materials – version 1 Page 13 of 15
COMMENTS:
9.3 BATCH TESTING & CERTIFICATION
9.3.1 Is a procedure in place for the handling of results that are out of specification (OOS
Yes No
procedure)?
9.3.2 Are out-of-specification results investigated and documented? Yes No
9.3.3 Is re-sampling performed according to a written procedure? Yes No
9.3.4 Are authentic certificates of analysis (CoA) issued for each single batch? Yes No
9.3.5 Are name and address of your manufacturing site stated on the CoA? Yes No
COMMENTS:
9.4 RETAIN SAMPLES
9.4.1 Are identified reserve samples of each batch of product retained? Yes No
9.4.2 Are reserve samples retained for at least one year after the retest date? Yes No
9.4.3 Are reserve samples retained for at least three years after distribution? Yes No
9.4.4 Is the retain sample size at least twice the amount required to perform all
Yes No
specification testing?
COMMENTS:
9.5 STABILITY
9.5.1 Is a written stability program in place? Yes No
9.5.2 Is the expiration, re-test date and storage conditions assigned to the material based
Yes No
on stability testing?
9.5.3 Are the stability chambers (re) qualified? Yes No
9.5.4 Is the qualification of the stability chambers documented? Yes No
9.5.5 Do you perform monitoring of the conditions for the stability chambers? Yes No
COMMENTS:
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Questionnaire for Manufacturers of Critical Raw Materials – version 1 Page 14 of 15
10. Comments / References
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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Questionnaire for Manufacturers of Critical Raw Materials – version 1 Page 15 of 15
11. Statements
Required statements / documents to be attached to this Questionnaire:
Current Route of Synthesis
BSE / TSE
GMO
Metal Impurities
Elemental Impurities Statement for excipients
Residual Solvents
Melamine
Pesticide
Phtalate
Toxic compound
Latex
Gluten
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:
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