What is the difference between validation, verification, qualification and calibration?

1How regulators define the four terms.

The EU GMP glossary and ICH Q7 give the working definitions; WHO’s validation guideline adds one for verification.¹²³

The EU definitions run the same way: qualification is proving “that any equipment works correctly and actually leads to the expected results”, and validation is proving that “any procedure, process, equipment, material, activity or system actually leads to the expected results”. The EU glossary adds that “the word validation is sometimes widened to incorporate the concept of qualification”.¹ PIC/S’s recommendations on qualification and validation, PI 006-4, use the terms the same way: in that document, qualification refers to facilities, utilities, equipment and systems, and validation to processes, cleaning and methods.⁴

2How they fit together.

Calibration, qualification and validation build on one another. Calibration comes inside qualification: Annex 15 lists “calibration of instrumentation” among the things installation qualification should include, and a process validation protocol lists the equipment to be used with its calibration status.⁵ Qualification then comes before process validation. Annex 15 says equipment, facilities, utilities and systems used for process validation should be qualified and test methods validated for their intended use.⁵ ICH Q7 states that qualification is part of validation, but “the individual qualification steps alone do not constitute process validation”.²

FDA’s process validation guidance of January 2011 uses the same order. It defines process validation as “the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product”. Its Stage 2 includes qualifying utilities and equipment, including verifying they are “properly connected and calibrated”, and FDA says these activities “necessarily precede manufacturing products at the commercial scale”.⁶

Computerised systems split the same way. Annex 11 says “the application should be validated; IT infrastructure should be qualified”.⁷

3Where verification fits.

Verification is the most general of the four words, and GMP texts use it in several places. Annex 15 defines design, installation, operational and performance qualification each as “documented verification” of a particular claim.⁵ Elsewhere, the pairs below show the difference: verification checks that requirements are met, while validation shows that a procedure, method or process will meet them consistently.

The cleaning and process rows come from the Annex 15 glossary,⁵ the test method row from 21 CFR 211.194(a)(2) and 211.165(e),⁸ and the software row from FDA’s General Principles of Software Validation, which notes that the device Quality System regulation was harmonised with ISO 8402:1994, which treats “verification” and “validation” as “separate and distinct terms”, while many software texts use them interchangeably.⁹ For medical devices, 21 CFR 820.3 now takes its definitions from ISO 13485 and Clause 3 of ISO 9000, incorporated by reference since the Quality Management System Regulation took effect on 2 February 2026.¹⁰⁹

4What the regulations require of each.

Calibration. US drug manufacturers must calibrate, inspect or check automatic, mechanical and electronic equipment under a written programme,⁸ and calibrate laboratory instruments “at suitable intervals” under a written programme with specific directions, schedules, limits for accuracy and precision, and remedial action when limits are not met. Instruments that don’t meet their specifications “shall not be used”.⁸ EU GMP Chapter 3 asks for measuring, weighing, recording and control equipment to be calibrated and checked at defined intervals, with records kept.¹¹

Qualification. Annex 15 sets out the stages from user requirements through design qualification, factory and site acceptance testing, and installation, operational and performance qualification, and expects equipment, facilities, utilities and systems to be evaluated at an appropriate frequency to confirm they remain in a state of control.⁵

Validation. Annex 15 calls it “a GMP requirement” to control the critical aspects of operations “through qualification and validation over the life cycle of the product and process”.⁵ In the US, 21 CFR 211.110(a) requires control procedures to “validate the performance” of manufacturing processes that may cause variability, and 211.113(b) requires validation of all aseptic and sterilisation processes.⁸ FDA states that process validation is legally enforceable under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act.⁶

5How it runs in Seal.

In Seal’s commissioning and qualification blueprint, each requirement links to the IQ, OQ and PQ tests that verify it, and test equipment carries its calibration range, status, due date and standards traceability. Because that eligibility is recorded against each execution, a later calibration failure identifies the tests that used the instrument and opens an impact assessment. The calibration management blueprint keeps each point’s as-found and as-left results, procedure and reference standard, and links the event to the batches, tests and qualification runs that used the instrument.

The process validation blueprint runs PPQ protocols on the same platform as manufacturing, testing and quality, and carries the reviewed controls and residual risks into continued process verification.