USP <1220> - Analytical Procedure Life Cycle

What it says

This chapter describes a life cycle approach to analytical procedures, from design through ongoing performance verification. It introduces the Analytical Target Profile, which states the intended purpose and required performance of the procedure, followed by procedure design and development, procedure performance qualification, and ongoing procedure performance verification, with change managed through the life of the procedure.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• It treats a method as something managed over time, instead of validated once and forgotten.
• The Analytical Target Profile sets out what the result has to do, so the procedure is designed to meet a defined need.
• Ongoing verification, for example trending of system suitability and results, shows whether the procedure still performs.

What inspectors look for

• Whether the procedure is fit for its intended purpose, with that purpose defined.
• Whether performance is monitored after the procedure is in routine use.
• Whether changes to the procedure are assessed and controlled.

Related regulations