Imagine two suppliers reporting the same protein value for the same product. One measured the value on its own bench; the other sent its sample to a laboratory outside the facility. Even if the numbers are the same, they carry different weight for the buyer. The difference stems not so much from the technical quality of the measurement as from the relationship between the party making the measurement and the result.
This article addresses the question of who carries out the analysis. How to read the fields of an analysis report was described in the article on the certificate of analysis; the subject here is the position of the party that prepares that report.
First, second and third party
In the field of conformity assessment, measurements are divided into three groups according to the relationship between the party carrying them out and the product. This distinction is not a ranking of value but a framework showing which question each measurement answers.
| Measurement | Who carries it out? | Strength | Limitation |
|---|---|---|---|
| First party | The producer itself | Fast and can be repeated frequently during production | The party measuring and the party selling are the same |
| Second party | The buyer or a unit acting on the buyer's behalf | Carried out according to the buyer's own criteria | Every buyer has to set up every method |
| Third party | A laboratory independent of both parties | The result can be accepted by both sides of the commercial relationship | It speaks only for the sample that reaches the laboratory |
The three kinds of measurement are not mutually exclusive. In a well-functioning supply relationship, the producer carries out its own process control, the independent laboratory establishes the defining values of the batch, and the buyer verifies at acceptance a few parameters it considers critical for its own use.
This distinction becomes even more important for a material of biological origin such as venom. Whereas the quality of a synthetic chemical is often defined by a single main component, venom is a mixture of dozens of components, and its identity is described by a profile. An impartial measurement of this profile is the buyer's first step in getting to know the mixture.
What does independent measurement give the buyer?
The first is impartiality. A report from a laboratory with no commercial interest in whether the result turns out good or bad can be accepted in the buyer institution's internal audit without further explanation. When the source of material used in publicly funded projects or in work that will lead to publication is questioned, a third-party report serves as ready evidence.
The second is methodological competence. Methods such as reversed-phase chromatography, spectrophotometry and electrophoresis require both instruments and experienced staff. Working with a laboratory that runs these methods routinely, instead of building the entire infrastructure at a production facility, increases the reproducibility of the results. The methods themselves were described in the articles on HPLC and UV-Vis.
The third is savings in time and cost. Once the defining values have been established independently, each buyer does not need to repeat the same analyses from scratch. The buyer can devote its limited resources to verifications specific to its own experiment.
The fourth is comparability. Batches measured in the same laboratory by the same method can be compared directly with one another. If each batch were measured in a different place, it would be impossible to tell how much of the difference between batches comes from the material and how much from the method. The choice of laboratory is therefore treated not as a one-off decision but as a long-term relationship; when the laboratory changes, measuring the same sample in both places during the transition preserves the continuity of the series.
How to read the scope of accreditation
The international benchmark for laboratory competence is ISO/IEC 17025, the standard published for testing and calibration laboratories; in Türkiye, accreditation to this standard is granted by the Turkish Accreditation Agency (TÜRKAK). There is a detail here that is often overlooked: accreditation is granted not to the laboratory as a whole but to specific methods. The fact that a laboratory is accredited does not mean that every measurement in its report was made within the scope of accreditation. Which methods are in scope is listed in the annex to the laboratory's accreditation certificate and is usually indicated in the report by a separate mark.
Competence is tested not only by certification but also through interlaboratory comparison programmes. In these programmes, the same sample is sent to a large number of laboratories and each result is assessed against the consensus value. Regular participation is one of the indicators that a laboratory produces consistent results over time.
What does independence not cover?
An independent laboratory measures the sample delivered to it. How well the sample represents the batch, the conditions under which it was stored and shipped, and the time that passed before it reached the laboratory depend on the producer's record-keeping. The value of an independent report is therefore complete only when it is combined with traceability records on the production side.
A report, moreover, gives information only about the parameters measured. No conclusion can be drawn about a property not included in the report. Aspects that have not been assessed, such as biological activity or microbiological load, are planned separately if the buyer's intended use requires them.
A difference between the buyer's own measurement and the independent report is also assessed within this framework. Different methods, different instruments and the time the sample spent in transit can mean that the results do not match exactly. Small differences are normal; in the case of a marked deviation, the two parties look for the cause together by comparing their methods and the sample's history.
The following questions help in testing the reliability of a report:
- Are the laboratory's name and address clearly stated in the report?
- Does the laboratory have a partnership or any similar organizational link with the producer?
- Does the report give the sample delivery date and the analysis date separately?
- Are the instruments used and the measurement conditions stated?
- Can the report be confirmed by contacting the laboratory directly?
How this works for our reference batch
The sample from our reference batch was delivered to an independent laboratory on 30.06.2026; the analysis report is dated 04.07.2026. Having the analysis carried out outside the facility is a deliberate choice: it separates the party doing the measuring from the party doing the producing. The measurements used a Shimadzu Prominence-i LC2030 3D chromatography system and a Shimadzu UV-1900i spectrophotometer. The report covers the UV-Vis spectrum, pH, protein concentration by standard curve, SDS-PAGE, RP-HPLC and peptide analysis. The values belong to this batch and may vary from batch to batch. The methods and all the values found are published on the analysis page.
