Pharma Supplier Qualification Questionnaire Template
A supplier qualification questionnaire is the first step in approving a source of API, excipient or packaging. This template builds a ready to send document that asks the questions quality teams use most and leaves clear spaces for evidence.
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Pharma Supplier Qualification Questionnaire Template
Supplier Qualification Questionnaire
From: Acme Pharma Ltd (Supplier Quality Manager) To: Sunrise Chemicals Pvt Ltd Material: Povidone K30 (excipient) Category: Excipient Issued: 2026-10-20 Please reply by: 2026-11-10
Please answer every question. Attach evidence where requested. Answers are held in confidence and used only for the qualification of Sunrise Chemicals Pvt Ltd as a supplier to Acme Pharma Ltd.
A. Company and site
| No. | Question | Response | Evidence attached |
|---|---|---|---|
| A1 | Legal entity name, site address, and manufacturing site of the material | ||
| A2 | Is the material made, tested and packed at the same site? If not, list all sites | ||
| A3 | Do you use subcontractors or traders for any step? | ||
| A4 | Number of employees in manufacturing and quality |
B. Quality system and GMP
| No. | Question | Response | Evidence attached |
|---|---|---|---|
| B1 | Quality certifications held (for example ISO 9001) and expiry dates | ||
| B2 | GMP standard followed for this material (for example IPEC-PQG, ICH Q7, or other) | ||
| B3 | Date and result of last regulatory or customer audit | ||
| B4 | How do you control changes to process, site, raw materials or specifications, and how do you notify customers? | ||
| B5 | Describe your deviation, complaint and recall procedures | ||
| B6 | Is the material tested against a pharmacopoeial monograph? Which? |
C. Documents requested
| Document | Provided (Y/N) | Date / version | Remarks |
|---|---|---|---|
| Certificate of analysis for the last three lots | |||
| Specification and method summary | |||
| Allergen, BSE/TSE and residual solvent statements as applicable | |||
| Change notification agreement or quality agreement draft |
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A generic starting point, not a regulatory form. Tailor questions to the material risk. For APIs, a risk based supplier audit is usually expected in addition to a questionnaire. This is not legal advice.
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How to use it
Enter your company, the supplier, the material and the category. The generated document has four parts: site and company information, quality system and GMP, documents requested, and sign-off. Send it as a Word file so the supplier can answer in the table, or print the PDF and fill by hand. Review the answers, request missing evidence, then decide whether an on-site or remote audit is needed.
- Tailor the questions to the material and its risk to the patient
- Keep the completed form with the supplier file and audit report
The regulatory background
EU GMP Chapter 5 requires that suppliers are approved and that the manufacturer is responsible for the quality of starting materials. For APIs, ICH Q7 section 7 describes the supplier qualification and EU rules require audits of API manufacturers. For excipients, the EU guideline on formalised risk assessment for excipients asks the manufacturer to identify the appropriate GMP based on the risk. In the US, 21 CFR 211.84 governs testing and approval of components.
Common mistakes
Companies sometimes qualify a trader instead of the actual manufacturer, accept a certificate without checking it against the specification, or let a quality agreement sit unsigned for months. Ask for every site involved in making and testing the material. Compare incoming certificate results with your own test results over time, and re-evaluate supplier status on a schedule that is tied to risk.
- Identify the real manufacturer and each manufacturing site
- Make sure change notification duties are written down
- Link approval status to the ERP vendor and material master so unapproved sources cannot be used
Frequently Asked Questions
Is a questionnaire enough to qualify an API supplier?
Usually not. Regulators expect a risk based decision which often includes an audit of the API manufacturer, review of documents and testing of samples. The questionnaire gives you the base information to plan that audit.
Do excipient suppliers need a GMP audit?
It depends on risk. Under the EU excipient risk assessment guideline, you consider the excipient type, source, use and supply chain to decide the level of GMP needed. High risk ones may require an audit; low risk ones may need only documents.
Should I include a quality agreement?
Yes for APIs and critical materials. A quality agreement sets responsibilities for change notification, deviations, testing and audits. Use the questionnaire answers to decide what the agreement must cover.
How often should suppliers be requalified?
Set a schedule based on risk and performance, often every one to three years, plus whenever there is a significant change or quality event. Record the schedule in your supplier management SOP.
If your approved supplier list lives apart from purchasing in the ERP, Netray can help enforce approved sources at the point of ordering and receipt.
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