Regulated laboratories must demonstrate that analytical instruments are suitable for their intended use. U.S. Pharmacopeia general chapter <1058> (analytical instrument qualification (AIQ)) defines the essential framework that your lab should follow.
As the only major pharmacopeia with a general chapter dedicated to AIQ, <1058> is a key regulatory reference and changes have global implications for instrument qualification.
When surveyed, however, 68% of laboratories were unaware of the differences between the obsolete 2008 version of <1058> and the current (2017) version. Specifically:
- User requirements must be documented.
- Design qualification must document why the instrument is suitable.
- Risk assessment is required.
- Qualification must be tied to user requirements.
- PQ, or performance qualification, testing is now a requirement.
In addition, the 2017 updates to USP <1058> more strongly aligned USP <1058> with GAMP 5 requirements for instrument qualification and software validation.
An integrated, life cycle-based approach to AIQ:
The Automated Compliance Engine (ACE) software that Agilent uses to provide AIQ services is compliant with USP <1058> requirements. For example, our equipment qualification plans (EQP) can be configured to ensure that operational qualification (OQ) meets user requirements—such as testing the range of use.
Stay compliant, and spend more time on what matters:
To help your lab comply with USP <1058> requirements, Agilent has developed four white papers. Through our Compliance Consulting Services, we can also help you implement cost-effective electronic qualification and align your SOPs to comply with USP <1058>.
Download our Whitepaper on how to comply with 2017 Version of USP<1058>