Checking a peptide lab report: lookups, registers and ISO 17025

A step-by-step way to check that a laboratory report is genuine, is about the sample it claims, and comes from a lab whose competence can be confirmed in a register the lab does not control.

By Touchstone PeptidesSeptember 22, 20269 minute read

A laboratory report is verifiable when three things can be checked from outside: that the named laboratory issued that report number for that sample, that the sample identifier ties to the lot in your hand, and that the laboratory's claims about itself, in particular "ISO/IEC 17025 accredited", appear in a register the laboratory does not control. A public lookup on the lab's website answers the first, a lot number matching across vial, packing slip and report answers the second, and an accreditation body's directory answers the third.

What a verifiable report contains

The content of an accredited test report is standardised. ISO/IEC 17025:2017 sets it out in clause 7.8.2.1, and FDA's own laboratory accreditation rule for food testing (21 CFR 1.1152) adopts the same clause by reference, requiring reports that "Include the name and street address" of the laboratory, display an identification unique to the report, and be "true, accurate, unambiguous, and objective". For a research peptide certificate, the same items are what make the paper checkable:

The laboratory's name and address, not a logo alone.
A unique report or job number.
A sample identifier, and a description of what was received (vial, powder, quantity, the lot number printed on it).
The date the sample was received and the date of analysis.
The method for each figure: HPLC with column, detector wavelength and gradient summarised; mass spectrometry with the instrument type; any content assay with its basis.
The numerical value and the acceptance limit for each test.
A named signatory, which the NVLAP handbook calls the "Approved Signatory", the person who authorises the report.

ICH Q7, the good-manufacturing-practice guidance for active ingredients, asks for the same things of a manufacturer's certificate: it "should list each test performed in accordance with compendial or customer requirements, including the acceptance limits", with the numerical value obtained for each, and certificates "should be dated and signed by authorized personnel of the quality unit(s) and should show the name, address, and telephone number of the original manufacturer". A report missing several of these is not necessarily false, but it is unverifiable, which for a buyer is the same problem.

Step one: check the report with the laboratory

Many independent laboratories in this market keep a public lookup page: enter a report number or a code printed on the report and the page returns the report the lab holds under that number. Where that exists, it is the first check, because it confirms the document was issued by the lab and has not been edited since.

The lookup proves that the laboratory tested a sample and reported those figures under that number. It does not prove where the sample came from. A laboratory reports on the material a client sends; it cannot see the vial on your bench. So the lookup verifies the document, and the sample identifier on the document has to be matched to your lot separately.

Two features of public lookups limit what they show:

Listing is usually at the client's option. A lab's public listing page shows the reports its clients chose to make public. A page full of high purity figures is a curated set, not a survey of what the lab sees. Draw no conclusion about a supplier from the reports it did not publish, and draw no conclusion about a market from a listing.
The sample description is the client's. The lab records what it was told the sample is. A report headed with a peptide name and a lot number confirms that the lab received something labelled that way. Identity by mass spectrometry confirms the molecule; nothing on the report confirms the lot number on its own.

If a laboratory has no public lookup, the report can still be checked by writing to the lab with the report number. A laboratory that will not confirm whether it issued a document is a laboratory whose reports cannot be verified, whatever else is true of it.

Step two: tie the report to the lot in your hand

A genuine report about a different lot is worth nothing to you. Run the four checks in what a lot number is for: matching numbers on vial, slip and report, dates in order, a retest date from the manufacturer, and a lot you can find in a published index.

Then add one check that page does not cover: the report must be lot-specific, not "representative" or "typical". A representative certificate describes a product line rather than your material, and is the first of six ways a certificate misleads.

Where a supplier commissions its own independent test on a lot, ask for the chain: who drew the sample, from what, and when. On this site the second sample is drawn from the lot that arrived here and sent to an independent laboratory at our cost, and both reports carry the same lot number; the reasoning is in why we pay for a second laboratory.

What "ISO/IEC 17025 accredited" means

ISO/IEC 17025 is the international standard for the competence of testing and calibration laboratories. ISO does not accredit anyone. Accreditation is granted by an accreditation body that assesses the laboratory against the standard; in the United States the recognised bodies include A2LA, ANAB and NIST's NVLAP. A laboratory is "ISO 17025 accredited" only if such a body has assessed it and issued a certificate with a scope.

Three details decide whether the phrase means anything on a peptide report:

Accreditation is for a scope, not a building. NVLAP's handbook states that a certificate of accreditation "is always issued with a Scope of Accreditation". The scope lists the fields, methods and sometimes the analytes the lab was assessed for. A laboratory accredited for environmental water testing is accredited; it is not accredited for HPLC purity of synthetic peptides. Ask which scope covers the report you are holding.
Accredited data must be marked. Under NVLAP's rules a report mixing accredited and non-accredited data "shall clearly identify the data that are not covered by the accreditation", and a laboratory may not use the accreditation symbol on "a report that contains no accredited data". A report that carries an accreditation logo but no statement of which figures are covered has not told you what the logo applies to.
Accreditation says the lab is competent to run the method it was assessed for. It does not say the sample was representative, that the client described it truthfully, or that the figure is the one another competent laboratory would obtain on the same day. The last point is a measurement question, covered in why two laboratories get different numbers on one lot.

"Registered", "certified", "compliant with ISO 17025" and "operates to ISO 17025 principles" are not accreditation. They are descriptions a laboratory writes about itself.

Step three: check the accreditation body's register

An accreditation claim is checked in the register of the body that granted it, never on the laboratory's own site.

Find the body. The report or the lab's certificate names it. If the body is unfamiliar, ILAC keeps a signatory search that "provides a current list of all accreditation bodies that are signatories to the ILAC MRA", the mutual recognition arrangement under which signatories accept one another's accredited reports. ILAC notes that "in many cases, a link to the accreditation body's online directory of accredited facilities is also provided".
Search the directory. A2LA's public directory searches by keyword across "scope, test method, certificate no., organization name" and can be filtered to its ISO/IEC 17025 testing programme. It also publishes a list of suspended, withdrawn and inactive certificates, and a separate page on false claims of accreditation. NVLAP publishes a directory of accredited laboratories and a search by test method or calibration parameter.
Open the scope. The directory entry links to the current scope document. Read it for the field (chemical testing), the technique (liquid chromatography, mass spectrometry) and any analyte restriction. Note the certificate's expiry and status.
Match the name. The legal name on the register should match the name on the report. Trading names, group companies and "affiliated" laboratories are where claims drift.

If a laboratory says it is accredited and the body's register does not show it, ask the laboratory for its certificate number and check again. If that fails, the claim is unverified, and the report should be read as an unaccredited report, which is not worthless but is a different document.

In-house versus independent

An in-house certificate is issued by the party that made or sells the material; an independent report comes from a laboratory with no stake in the figure. Both can be accurate, and the numbers alone do not say which is which. ICH Q7 requires that where a repacker, agent or broker issues a new certificate it "should show the name, address and telephone number of the laboratory that performed the analysis" and reference the original manufacturer's batch certificate. A certificate that does not say who ran the test has hidden the one fact that decides its category.

FDA's manufacturing rules take the same line: 21 CFR 211.84(d)(2) lets a manufacturer accept a supplier's report of analysis only if it runs its own identity test and validates the supplier's figures at intervals. A buyer applying that standard to a research vial asks for an independent report at some interval and compares it against the supplier's.

What verification cannot tell you

Every step above verifies documents. None of them verifies material. A verified, accredited, lot-specific report can still describe a retained sample tested at release rather than the vial that shipped; can describe a lot that was later repackaged; and can be accurate to the day it was issued and silent about what happened in transit afterwards. The remedies are a second sample drawn after arrival, a lot number that stays published so it can be checked later, and a supplier who will say in writing who drew which sample when. Our own chain is set out in the provenance section.

The checklist

Check	Where	What it proves
Report number returns the same document	Laboratory lookup page or a written confirmation	The lab issued it and it is unedited
Lot number identical on vial, packing slip, report	Your bench	The report is about your material
Method, date, signatory, acceptance limits present	The report	The report is complete enough to be checked
Laboratory named with address	The report	You know who to ask
"Accredited" appears in the body's register with a live certificate	A2LA, ANAB, NVLAP or the ILAC signatory's directory	The claim is real
Scope covers chromatography and mass spectrometry of peptides	The scope document linked from the register	The claim applies to this report
Accredited and non-accredited figures are distinguished	The report	You know what the logo covers
Who drew the sample, from what, when	The supplier, in writing	The sample is the lot, not a retained aliquot

Sources

For laboratory research use only. Not a drug, not a supplement, and nothing here is a claim about what any of this material does in a person or an animal.

Two things before you come in.