Usage Examples
- The validation request names the analytical procedure, intended purpose and acceptance criteria before the study begins.
- The review distinguishes evidence for the manufacturing process from evidence for the electronic record system.
What is Validation?
Validation is a documented assurance program showing that a specified process, method or system can consistently meet predetermined acceptance criteria; the evidence and scope depend on what is being validated.
Validation connects an assurance claim to evidence about a defined process, method or system. In pharmaceutical quality, the word is broader than manufacturing process validation. ICH Q7's glossary supplies that broader terminology, while its validation-policy section identifies several applications. A request saying only “validation complete” leaves the object and acceptance criteria unclear. Identify both before evaluating the claim. ICH Q7 sections 20 and 12.10.
Validation takes different forms according to the question being answered. Analytical procedure validation evaluates fitness for an intended purpose under ICH Q2(R2). Manufacturing process validation gathers evidence across process design and commercial production under FDA's process guidance. Electronic-record system validation addresses system performance within applicable Part 11 requirements. Evidence for one object does not automatically establish the status of another.
Validation review therefore begins by naming the object, intended result, criteria and applicable framework. For an analytical study, Q2(R2) describes a protocol before execution and a report summarizing results. For manufacturing, FDA describes continued process verification during routine production. The guidance recommendations below retain their stated scope; they are not a universal procedure or a substitute for applicable regulations.
Not to be confused with
- Process Validation
- the narrower manufacturing application covers process design, qualification and continued verification. Use the process validation entry for that lifecycle; validation also encompasses methods and systems. [FDA Process Validation guidance section II.B]
What you must do
- 1For API process validation under ICH Q7, establish a written protocol and obtain review and approval from the quality unit and other designated units. This is the guidance's scoped recommendation.ICH Q7 section 12.20
- 2For an analytical procedure, define the intended purpose, performance characteristics and criteria in the validation protocol before the study; summarize the results in a report.ICH Q2(R2) section 2.1
- 3For a closed electronic-record system within Part 11, validate accuracy, reliability, consistent intended performance and the ability to detect invalid or altered records.21 CFR 11.10(a)
- 4For drug manufacturing process validation, include ongoing assurance during routine production instead of treating qualification as the entire lifecycle.FDA Process Validation guidance section II.B
Common mistakes
Leaving the object unspecified
identify whether the claim concerns a process, analytical procedure or system; the supporting evidence answers different questions. [ICH Q7 sections 20 and 12.10]
Setting analytical criteria after the study
Q2(R2) places the intended purpose, characteristics and criteria in a protocol prepared before validation. [ICH Q2(R2) section 2.1]
Treating process qualification as final closure
FDA's lifecycle includes continued process verification during routine manufacturing. [FDA Process Validation guidance section II.B]
Use the right evidence
When reviewing a validation package, identify the specific object and follow the applicable source above. Record an unresolved scope question explicitly instead of assuming the request means manufacturing process validation. For the manufacturing application, continue with the process validation glossary.
When This Matters
- The validation request names the analytical procedure, intended purpose and acceptance criteria before the study begins.
- The review distinguishes evidence for the manufacturing process from evidence for the electronic record system.
Frequently Asked Questions
Computer system validation evaluates whether a specified computerized system performs its intended tasks with appropriate evidence. The scope depends on the application and applicable requirements. For closed electronic-record systems within Part 11, section 11.10(a) requires validation addressing accuracy, reliability, intended performance and detection of invalid or altered records.
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