Peptide supplier qualification questionnaire: questions to send and answers to expect

How to send it and how to read the replies

Send the questionnaire in writing, the same version to every supplier, with a reply date. ISO/IEC 17025 clause 6.6.3 expects a laboratory to communicate its requirements to external providers, including what is to be supplied and the acceptance criteria, and a questionnaire with your acceptance criteria attached does that. [4]

Read each reply for three things. Does it answer the question that was asked? Does it name something checkable: a company, an accreditation number, a lot number, a document? Is the document attached or offered? A reply that says testing is rigorous and quality is guaranteed answers none of these. Record every answer with its date in the supplier file, including non-answers.

The questions below borrow from ICH Q7, which describes what agents, brokers and distributors of pharmaceutical ingredients should be able to provide. [1] Research-chemical suppliers are not bound by Q7, so treat it as a measure of how much they can show, not a compliance test.

Manufacturing site and supply chain

Start with who made the peptide. Q7 expects a buyer of a critical material to know the manufacturer's name and address when the seller is not the manufacturer, and expects distributors to give customers the name of the original manufacturer and the batch numbers supplied. [1] Many storefronts resell material made elsewhere; that is not disqualifying, but refusing to say so leaves you unable to trace a problem.

Ask whether the seller repackages or relabels. Q7 treats repackaging and relabelling as activities that need controls against mix-ups and loss of identity or purity, and expects stability data if material is moved into a different container type. [1]

• Who manufactures this peptide, and at what address?
• Do you repackage, relabel or aliquot before shipping? If so, where and under what records?
• Will the original manufacturer's batch number appear on our documents?

Testing laboratory and accreditation

A certificate is only as good as the laboratory behind it. Q7 expects a certificate to list each test with acceptance limits and numerical results, to be dated and signed, and, when issued by an agent or broker, to name the laboratory that did the analysis and reference the original batch certificate with a copy attached. [1]

Ask for the testing laboratory's name and accreditation details, then check the accreditation body in the ILAC MRA signatory search and the laboratory's scope with that body. ILAC says its MRA signatories are accreditation bodies that have been peer evaluated against ISO/IEC 17011, and its signatory search lists each one with the scope of its recognition. [2]

• Which laboratory performs HPLC and mass spectrometry for each lot?
• Is that laboratory accredited, by which body, and under what certificate number?
• Are the identity and purity tests within its accredited scope?
• Can you supply the laboratory's original report for the lot we will receive?

Lot traceability, change notification and complaints

Q7's traceability list for distributors is the benchmark: original manufacturer and address, purchase orders, transport documents, receipt documents, the manufacturer's batch number, all authentic certificates including the original manufacturer's, and the retest or expiry date. [1] Ask the supplier which of these it keeps and for how long.

For changes, Q7 recommends that an ingredient maker's customers, the dosage form manufacturers, be notified of changes to established production and process controls that can affect quality. [1] Ask whether the supplier will tell you before a change in manufacturer, synthesis route, salt form or testing laboratory. For complaints, Q7 expects distributors to keep records of complaints and recalls and, where warranted, to review them with the original manufacturer. [1]

• Which traceability records do you keep for each lot, and for how long?
• Will you notify us before changing manufacturer, salt form, route or testing lab?
• How do we raise a complaint, who investigates, and what do you send back?
• Have you issued any recall or customer notification in the last two years?

Storage, shipping and safety documents

OSHA requires chemical manufacturers and importers to provide distributors and employers with an appropriate SDS with the initial shipment of a hazardous chemical, and requires distributors to pass on SDSs and updated information. [3] The SDS format includes handling and storage in Section 7 and transport information in Section 14, so it is a natural place to check that the supplier's stated storage and shipping conditions agree with each other. [3]

• Please send the current SDS for each product we may order, with its revision date.
• At what temperature is the material stored before dispatch, and how is it packed for transit?
• Do you ship to our country, by which carrier, and on what delivery terms?

The questionnaire in one table

Use this as the review sheet when replies come back. Nothing is scored: each row is either backed by a document or it is not, and the gaps decide what you ask next.