United States Pharmacopoeia (USP) has two General Chapters summarizing the lifecycle approaches and requirements to ensure data quality by demonstrating metrological (<1058>) and procedural integrity (<1220>).
United States Pharmacopoeia (USP) General Chapter <1058> on Analytical Instrument Qualification (AIQ) is undergoing a revision process which intends to enhance the current version to a fully lifecycle approach and support General Chapter <1220> on Analytical Procedure Lifecycle.
General Chapter <1058> is intended to provide a framework establishing ‘fitness for intended use’ of instruments and systems for use within analytical procedures generating results which are ‘fit for intended purpose’ in accordance with General Chapter <1220> for establishing compliance with the standard monographs of the USP.

Subject area:
Drug Products & APIs

Objectives (If applicable):
N/A

Target Audience (If applicable):
Instrument and system manufacturers, industry end users (such as pharmaceutical Industry research and development laboratory staff, QC laboratory staff, metrology groups staff in centralized laboratories), contract research and development and contract pharmaceutical manufacturers laboratory staff and related functions staff, industry associations and groups as well as regulators,
Analytical Chemistry and Pharmaceutical Science graduate students and postdocs.
Analytical Chemistry and Pharmaceutical Sciences faculty
Validation and metrology engineers, staff and managers, independent consultants