Laboratories · Method Validation
Analytical Method Validation Consulting
The short answer
Method validation demonstrates that an analytical procedure is suitable for its intended purpose. The characteristics evaluated depend on what the method is used for — an assay, an impurity limit test and an identification test do not require the same package, and treating them identically wastes laboratory capacity.
Why this matters
- Every release, stability and investigation decision depends on method performance being established and maintained.
- Methods validated in development and never re-evaluated after years of drift are a recurring source of unexplained OOS results.
- Method transfer failures usually reveal a robustness gap that the original validation did not challenge.
Applicable regulations and standards
- ICH Q2(R2)
- Validation of analytical procedures: characteristics and study design.
- ICH Q14
- Analytical procedure development and lifecycle management.
- 21 CFR 211.165(e) / 211.194(a)(2)
- Accuracy, sensitivity, specificity and reproducibility requirements and records.
- USP <1224> / <1225> / <1226>
- Transfer, validation of compendial procedures and verification of compendial procedures.
What our consultants actually do
- Define which validation characteristics apply based on method purpose and write the protocol accordingly
- Design robustness and intermediate precision studies that actually challenge the method
- Support verification of compendial methods, which is frequently confused with full validation
- Plan and execute method transfer using comparative testing or co-validation, with justified acceptance criteria
- Assess legacy methods and prioritize revalidation where performance has drifted
- Establish lifecycle method management: periodic review, change control and performance trending
Across the product lifecycle
01 / DEVELOP
Method understanding and operating ranges captured during development.
02 / SCALE
Sample matrix changes evaluated as process scale changes.
03 / TRANSFER
Comparative testing between sending and receiving laboratories.
04 / VALIDATE
Purpose-appropriate validation with justified acceptance criteria.
05 / MANUFACTURE
System suitability performance monitored, not just passed.
06 / MAINTAIN
Periodic review, revalidation on change and trend evaluation.
Problems we are usually called about
- Full validation performed on a compendial method that required verification, and vice versa
- Robustness studies that vary parameters within ranges the method never encounters
- Acceptance criteria set after the data was generated
- System suitability criteria so wide they cannot detect degradation
- Method changes managed as documentation updates with no revalidation assessment
Typical deliverables
- Method validation strategy and protocol set
- Robustness and intermediate precision study designs
- Method transfer protocols and comparative data evaluation
- Legacy method assessment and revalidation priority list
- Method lifecycle management procedure
Frequently asked
- What is the difference between method verification and validation?
- Verification demonstrates that a compendial or previously validated method performs suitably under your actual conditions, matrix and equipment. Validation establishes the performance characteristics of a method for the first time. Verification is narrower, but it is not optional.
- Does a method need revalidation after a change?
- It needs an assessment through change control. Changes to column chemistry, sample preparation, detection or matrix commonly require at least partial revalidation of the affected characteristics.
- How do we transfer a method to a contract laboratory?
- Usually through a comparative testing protocol with pre-defined acceptance criteria, executed on the same samples, supported by receiving-laboratory training and equipment suitability. Co-validation is an alternative where comparative testing is impractical.
References
More for laboratories
GLP and GMP laboratory compliance, data integrity and analytical operations.
- Data IntegrityLaboratory data integrity is a question of whether every reported result can be reconstructed from complete, attributable, contemporaneous records.
- GLP ComplianceGood Laboratory Practice under 21 CFR Part 58 governs nonclinical safety studies intended to support applications.
- GMP Laboratory ComplianceA GMP quality control laboratory is judged on laboratory controls: qualified instruments, validated methods, controlled reference standards, complete records and investigations that reach a conclusion.
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