Minimize your audit and regulatory inspection risk while complying with the latest USP <1058>
Instruments within regulated laboratories are required to be qualified periodically with adherence to the 2017 USP <1058> Analytical Instrument Qualification (AIQ) guidelines.
Pharmaceutical labs—or any lab producing results subject to regulatory requirements—must demonstrate and document the suitability of analytical instruments for their intended use. Labs can address these requirements by performing an analytical instrument qualification.
The United States Pharmacopeia is the only major Pharmacopeia with a general chapter dedicated to AIQ: USP <1058>. Therefore, changes to <1058> are of global importance. The 2017 version of USP <1058> is a key regulatory document with significant implications for your laboratory.
Agilent takes an integrated, life cycle-based approach to AIQ. We can help you implement a cost-effective qualification process and align your SOPs to comply with the 2017 USP <1058> requirements.
Complying with the Revised USP General Chapter on Analytical Instrument Qualification
Independent Consultant Bob McDowall and Agilent Strategic Compliance Specialist Paul Smith explore how USP general chapter <1058> has changed. They will also provide insight into complying with revised USP <1058> requirements.
*The need to include a specific Requirements Trace Matrix in the qualification life cycle is dependent on the intended use, instrument complexity, and company policy. GAMP is a registered trademark of ISPE. See ISPE website for GAMP publications: www.ispe.org/publications/guidance-documents
Integrated approach to hardware qualification and software validation
Significant expansion of software requirements—combined with the removal of instrument examples for groups A, B, and C—means that USP <1058> is now more closely aligned with GAMP 5.
Historically, USP <1058> has simplified the process of introducing group A and B instruments into regulated laboratories. The 2017 update extends this benefit to some group C instruments.
However, the 2017 USP <1058> requirements specify a risk assessment to identify a category for each instrument. Therefore, labs will have to justify their instrument categorizations, and update their procedures to consistently define categorization based on instrument use.
Together, these changes mean that the 2017 USP <1058> can now be considered a continuum of qualification options aligned with the GAMP Good Practice Guide (GPG) for Laboratory Computerized Systems (ISBN 978-1-936379-49-1) and GAMP 5 (ISBN 1-931879-61-3). Specifically:
Use USP <1058> for standard instruments (for example, HPLC, GC).
Use GAMP GPG for complex instruments (for example, Q-TOF).
Use GAMP 5 for Bespoke software validation.
What this means for your lab
In order for your lab to be compliant, you must align your AIQ with the 2017 USP <1058>. This includes all associated SOPs and AIQ life-cycle policy documents.
Agilent CrossLab compliance consultants are available to help assess your Computer System Validation (CSV) risks and implement/validate your systems and software.
*Adapted with permission from ISBN 978-1-84973-662-6.
The significance of data integrity
Regulatory audit findings associated with data breaches are prompting regulatory agencies worldwide to look more closely at data integrity. For a time, this meant that less attention was paid to traditional audit focus areas, such as AIQ. However, recent FDA 483s indicate that regulators have started looking at the data integrity, traceability, and technical content of AIQ reports in detail once again.
The data quality triangle remains unchanged in the 2017 USP <1058>. However, from a data integrity perspective, the triangle has evolved into the model shown here. In particular:
AIQ is the foundation of USP <1058> Data Quality Triangle.
Repeat work or rerun must be managed and explained (documented).
Data traceability is now a key requirement.
Data governance is now the foundation of all quality data.
What this means for your lab
Data integrity issues will drive more regulatory action than ever before. To successfully defend your results, you must be prepared to prove that your data have not been compromised.
In addition to providing Computer System Validation (CSV) services, Agilent CrossLab compliance consultants can help you perform data integrity gap analysis and method validation.
Facilitate compliance and quality throughout your lab
Focus on your science and meet tough regulatory demands
Maintaining a functioning laboratory means that you must ensure ongoing regulatory qualification and compliance. Agilent CrossLab compliance services—which is designed to comply with the new USP <1058> and includes repair qualification—can help you be confident that your equipment and processes conform.
Compliance tasks—which are critical to the success of labs operating in the regulatory space—are complex, costly, and time consuming. You can more efficiently minimize your regulatory risk, and stay current with industry standards and best practices, with Agilent CrossLab compliance consulting services.
The new changes to USP <1058> are significant and require laboratories to fundamentally re-evaluate their AIQ processes or risk regulatory noncompliance. Download our white paper series to learn how you can make your lab compliant with USP <1058>.