Understanding and Implementing USP 1058 Analytical Instrument Qualification

Overview:

Analytical instruments should be qualified to demonstrate suitability for the intended use. Despite the fact that instrument qualification is nothing new and companies spend a lot of time, it is a frequently cited deviation in FDA inspectional observations and warning letters.

Companies are unsure on what exactly to qualify or re-qualify, test and document. The main reason is that unlike for analytical methods there are no clear standards for equipment qualification. This has changed. The USP has developed a new standard for analytical instrument qualification (AIQ).

Reference material for easy implementation:

• SOP: Analytical Instrument Qualification for <1058>
• SOP: Allocating Analytical Instruments to USP <1058> categories
• SOP: Procedures and deliverables for USP <1058> categories

Areas Covered in the Session:

• FDA and EU analytical instrument requirements
• Most common inspection problems
• Terminology, scope and principles of US chapter <1058>
• AIQ and its relation to method validation, system suitability testing and quality control checks
• Essential steps for AIQ: DQ, IQ, OQ, PQ
• Purpose and contents of design qualification, installation qualification, operational qualification, performance qualification
• Allocation of instruments to the three categories A, B and C
• Procedures and validation deliverables for the three categories
• Recommendations for firmware and software validation
• Roles and responsibilities: QA, manufacturer, user
• Approach for automated systems (incl. firmware/computer systems)
• Qualification of existing systems
• Requalification after equipment changes (move, repair, firmware upgrade, hardware upgrade)
• Recommendations for effective implementation

Who Will Benefit:

• Laboratory Managers and Staff
• Analysts
• QA Managers and Personnel
• Regulatory Affairs
• Training Departments
• Documentation Department
• Consultants
• Validation Specialists