Understanding and Implementing USP 1058 Analytical Instrument Qualification
In this webinar Speaker is going to explain - how Analytical instruments should be qualified to demonstrate suitability for the intended use.And also USP has developed a new standard for analytical instrument qualification (AIQ).
Duration:
75 Minutes
Product Id:
501395
Access:
6 months
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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