Laboratory and method validation
Analytical and microbiological method validation, plus qualification of laboratory instruments. We cover residue methods for cleaning programs and compendial micro methods built around your SOPs.
Validation, verification, and suitability
A test result is only as defensible as the method behind it. Non-compendial analytical methods need validation of the characteristics that apply to their purpose, such as specificity, accuracy, precision, linearity, range, and detection and quantitation limits, as described in ICH Q2.
Compendial methods do not need full validation, but they do need verification under actual conditions of use per USP <1226>. For microbiological testing under USP <61> and <62>, that means method suitability testing with your products, your media, and a risk-assessed organism list.
Instruments and the methods that support validation
We qualify laboratory instruments such as incubators, viscometers, balances, TOC analyzers, and pH and conductivity meters, with IQ/OQ scaled to the instrument's complexity and use.
For cleaning and water programs, we validate the residue and monitoring methods those programs rely on, including swab and rinse recovery, so the lab data supports the validation conclusion.
What we deliver
- Method validation protocols and reports
- Compendial method verification
- Method suitability for USP <61> and <62>
- LOD and LOQ determination
- Residue methods for cleaning validation
- Lab instrument IQ/OQ and PQ
- Laboratory SOPs and test methods
Regulations and standards
- ICH Q2
- USP <61> and <62>
- USP <1225> and <1226>
- 21 CFR 211.160 and 211.194
- ISO 22716
Common questions
What is the difference between method validation and method verification?
Validation demonstrates that a new or non-compendial method is suitable for its intended purpose. Verification confirms that an already validated compendial method performs as expected in your lab, with your analysts, equipment, and samples.
When does a method need to be revalidated?
When a change could affect its performance: a new formulation or sample matrix, a change in instrument or critical reagent, or a change to the procedure itself. The extent of revalidation should be risk-based and documented through change control.
Do lab instruments need full IQ/OQ/PQ?
The level of qualification should match the instrument's complexity and its impact on results. Simple apparatus may need only calibration and verification, while computerized analytical systems need full qualification and data integrity controls.
Tell us about your project
Whether it's a single qualification or an audit on the calendar, send a few details and we'll reply within one business day.