RECORDREFERENCE OUTLINE

Supplier Qualification Questionnaire

A risk-based supplier qualification questionnaire and evaluation record for API, excipient, packaging, and service suppliers — capturing quality-system, GMP status, change-notification, and regulatory information, with a scored disposition. Supports the supplier controls required by ICH Q7 and EU GMP Chapters 5 and 7.

What a template is not

A template is a document baseline to adapt inside your own quality system. SPEQ does not approve, validate, or take responsibility for what you issue from it, and using one is not evidence of compliance.

CHECKING ACCESS

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REGULATIONS MAPPED
ICH Q7EU GMP Chapter 5EU GMP Chapter 7
DOCUMENT TYPE
Record
LAST UPDATED
August 2026
PURPOSE

A risk-based questionnaire and evaluation record capturing the quality-system, GMP-status, change-notification and regulatory information needed to qualify a supplier of materials or outsourced services, and scoring the response to a documented disposition. The questionnaire is evidence rather than correspondence: what makes it defensible is that the risk category was set first, the acceptance criteria were written before the response arrived, and the disposition was recorded against them.

What's Inside

✓Supplier and material or service identification, including manufacturing sites rather than the commercial address alone
✓Risk categorisation of the supplied material or service, performed before the questionnaire is issued
✓Quality-system and GMP questionnaire covering certification, inspection history, and quality-unit independence
✓Change-notification and regulatory-status questions, including notification triggers and timelines the supplier will commit to
✓Evidence checklist — certificates, licences, inspection outcomes, and specimen documentation requested with the questionnaire
✓Scored evaluation against acceptance criteria written in advance, with the scoring rationale recorded
✓Qualification disposition, requalification interval, and the conditions attached to a conditional approval

How to Use It

1Categorise the material or service by risk to product quality first; the category determines the depth of everything that follows
2Identify the actual manufacturing site, not the distributor or commercial entity, and qualify that site
3Write the acceptance criteria before issuing the questionnaire, so the evaluation cannot be fitted to the response
4Request supporting evidence alongside the questionnaire rather than accepting assertions for later verification
5Record a disposition — approved, conditional, or rejected — with the conditions and their review dates where conditional
6Set the requalification interval from the risk category and the outcome, and confirm the change-notification commitment in the quality agreement
DOCUMENT CONTENTS

The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.

—Document Control
› Document Information› Approval Signatures› Revision History› Distribution List
1Supplier and Material / Service
2Quality-System Questionnaire
3Evaluation and Disposition
REGULATORY CONTEXT

ICH Q7 requires manufacturers of active substances and their customers to evaluate and approve suppliers of critical materials, with the extent of evaluation based on risk. EU GMP Chapter 5 requires the qualification and approval of suppliers of starting and packaging materials, and Chapter 7 requires assessment of the suitability of any party performing outsourced activities. Neither prescribes your acceptance criteria or your requalification interval; those are the organisation's determinations and are recorded in this evaluation.

MAPPED STANDARDS
ICH Q7EU GMP Chapter 5EU GMP Chapter 7
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