Written and maintained by CASRAI Editorial Board
Last updated
Short answer
An analytical process is the full chain that turns a material into a reportable, defensible result: sampling, physical sample preparation, the analytical measurement, and an evaluation of the result that includes its measurement uncertainty. Eurachem’s 2024 VaMPIS guide treats sampling and the analytical method as one measurement procedure, and names measurement uncertainty as the characteristic that lets both be validated together.
Definition and scope
People use “analytical process”, “analytical method”, “analytical technique” and “analytical workflow” loosely, and the words overlap. This page uses them as follows, without claiming a single official vocabulary:
- Analytical technique: the measurement principle or instrument family, such as chromatography, mass spectrometry or spectroscopy. For the discipline-level view of techniques, see what analytical chemistry is.
- Analytical method or procedure: a technique fixed into a defined way of measuring a particular analyte in a particular material. The ICH guidelines discussed below use “analytical procedure”.
- Analytical process or workflow: everything around and including the method, from the way the sample is taken to the evaluation of the result.
The practical consequence is scope. A lab that validates only the instrument step has validated only part of the process.
How the analytical process runs in practice
Eurachem’s Validation of Measurement Procedures that Include Sampling (VaMPIS, 1st edition, English PDF published 17 December 2024) covers “the primary sampling (and physical sample preparation)” together with the analytical method or procedure. Its stated aim is to widen validation beyond the analytical method alone. It describes two routes: validating the whole procedure at once, or validating sampling afterwards when the analytical procedure has already been validated on its own.
Reading the stages in the order a sample experiences them:
- Primary sampling. The material taken must stand in for the larger body of material the result will be used to describe. VaMPIS counts this stage as part of the measurement procedure.
- Physical sample preparation. VaMPIS groups this with sampling rather than with the instrument.
- Analytical measurement. The technique and method are applied. This is the stage the ICH validation guidelines address.
- Evaluation of the result. The result is reported with its measurement uncertainty. VaMPIS names measurement uncertainty as “the key characteristic that enables validation of both the sampling and the analytical procedures”, supported by performance characteristics such as those in Eurachem’s fitness-for-purpose guidance.
These four stages are a reading aid built on VaMPIS’s grouping of sampling, preparation, analysis and uncertainty. They are not an official numbered model from any standards body.
Related concepts: methods, techniques and parameters
The table sets out what each primary source says about the part of the process it covers. Every row is taken from the sources listed at the end of this page.
| Source | Part of the process it addresses | What it says |
|---|---|---|
| Eurachem VaMPIS (2024) | Sampling, sample preparation and the analytical method together | Validation can cover the whole measurement procedure; measurement uncertainty is the characteristic that supports validating sampling and analysis. |
| ICH Q2(R2) | Validation of the analytical procedure | Applies to new or revised analytical procedures used for release and stability testing of commercial drug substances and products, chemical and biological; may apply to other procedures in a control strategy on a risk basis. Effective 14 June 2024. |
| ICH Q14 | Development and maintenance of the analytical procedure | Describes science- and risk-based approaches for developing and maintaining analytical procedures, with the same release and stability scope. Effective 14 June 2024. |
Analytical parameters: two different meanings
“Analytical parameter” is used for two things that are easy to confuse:
- Performance characteristics of a procedure: the ICH Q2(R2) page lists accuracy, precision, specificity, detection limit, quantitation limit, linearity and range. These describe how well the procedure performs. For the detection and quantitation limits in detail, see limit of detection versus limit of quantitation, and for the full validation guideline see ICH Q2(R2) analytical procedure validation.
- Procedure parameters and their ranges: the ICH Q14 page lists robustness, parameter ranges, lifecycle management and the analytical procedure control strategy as keywords. These concern the settings of the procedure itself and how they are managed over time. See ICH Q14 analytical procedure development.
How a procedure performed and the settings it was run at are therefore two separate records.
Technique-level examples
Technique choice sits inside the measurement stage. Worked examples on this site include the HPLC chromatogram.
Where it matters for labs and supply decisions
Two points follow directly from the sources.
Scope of a validation claim. ICH Q2(R2) and Q14 are written for release and stability testing of commercial drug substances and products. A procedure validated under Q2(R2) has been validated as an analytical procedure; VaMPIS adds the question of whether sampling and physical sample preparation were included in what was validated.
Where the instrument fits. The instrument and its consumables serve the measurement stage only. A well-qualified instrument does not remove the contribution of sampling and preparation to measurement uncertainty, because VaMPIS counts those stages as part of the procedure. Instrument qualification is a separate topic covered in USP analytical instrument qualification groups.
Common misunderstandings
- “Validating the method means validating the process.” Per VaMPIS, validation can be widened to include sampling and physical sample preparation; validating the analytical method alone leaves those stages outside the claim.
- “Uncertainty belongs only to the instrument.” VaMPIS names measurement uncertainty as the characteristic that supports validation of both the sampling and the analytical procedures.
- “ICH Q2(R1) is the current guideline.” The EMA page for ICH Q2(R2) gives a legal effective date of 14 June 2024 for the revised guideline.
- “Q2(R2) and Q14 cover every laboratory.” Their stated scope is release and stability testing of commercial drug substances and products, with other procedures covered only where a risk-based control strategy brings them in.
FAQ
What is the analytical process?
It is the chain from sampling and physical sample preparation through the analytical measurement to an evaluated result with its measurement uncertainty. Eurachem VaMPIS treats sampling and the analytical method as parts of one measurement procedure.
What is the difference between an analytical method and an analytical process?
A method or procedure is a technique fixed into a defined way of measuring a particular analyte in a particular material. The process also includes the way the sample is taken and prepared and how the result is evaluated. The vocabulary is used loosely, so check how a given document defines its terms.
What are analytical parameters?
The term covers performance characteristics (the ICH Q2(R2) page lists accuracy, precision, specificity, detection limit, quantitation limit, linearity and range) and procedure parameters and their ranges (an ICH Q14 keyword). They are two separate records.
Which guidelines are current for validating analytical procedures?
The EMA pages for ICH Q2(R2) and ICH Q14 both give an effective date of 14 June 2024, for release and stability testing of commercial drug substances and products.
Does validating the instrument validate sampling?
No. VaMPIS widens validation to include primary sampling and physical sample preparation precisely because validating the analytical method alone leaves those stages outside the claim.
Sources
- Eurachem, Validation of Measurement Procedures that Include Sampling (VaMPIS), 1st edition, 2024: eurachem.org/index.php/publications/guides/vampis (checked 2026-10-29).
- European Medicines Agency, ICH Q2(R2) Validation of analytical procedures: ema.europa.eu (checked 2026-10-29).
- European Medicines Agency, ICH Q14 Analytical procedure development: ema.europa.eu (checked 2026-10-29).
