Analytical Instrument Qualification
Provides a framework for the qualification of analytical instruments used in pharmaceutical testing, covering Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) with an additional specification for computerised instruments.
All analytical instruments used for quality control testing of pharmaceutical products, including HPLC, UV-Vis, IR/FTIR, dissolution apparatus, Karl Fischer titrators, and particle size analysers.
- 01Risk-based instrument categorisation: Group A (standard instruments), Group B (specified instruments), Group C (computerised instruments)
- 02DQ → IQ → OQ → PQ lifecycle with documented acceptance criteria
- 03Re-qualification programme triggered by: relocation, major maintenance, service, anomalous results
- 04Vendor qualification for Group C instruments
Current revision 2017. Stable guidance — no changes anticipated.
USP <1058>: frequently asked questions
Quick answers to common questions about USP <1058>.
What is USP <1058>?
USP <1058> — Analytical Instrument Qualification — is a standard issued by the United States Pharmacopeia (United States / International). Provides a framework for the qualification of analytical instruments used in pharmaceutical testing, covering Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) with an additional specification for computerised instruments.
Who does USP <1058> apply to?
All analytical instruments used for quality control testing of pharmaceutical products, including HPLC, UV-Vis, IR/FTIR, dissolution apparatus, Karl Fischer titrators, and particle size analysers.
What are the key requirements of USP <1058>?
USP <1058> requires, among other things: Risk-based instrument categorisation: Group A (standard instruments), Group B (specified instruments), Group C (computerised instruments); DQ → IQ → OQ → PQ lifecycle with documented acceptance criteria; Re-qualification programme triggered by: relocation, major maintenance, service, anomalous results; Vendor qualification for Group C instruments.
When was USP <1058> last updated?
The current version of USP <1058> dates from May 2017. Current revision 2017. Stable guidance — no changes anticipated.
Live openFDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.
Track the standards that move
When USP <1058> — or any GxP requirement — is revised, recalled against, or clarified by new guidance, the Weekly GxP Briefing surfaces it. Free, one email a week.