Instrument Qualification
Overview
Data Integrity and Instrument Qualification
NMR is an established analytical method used by all pharmaceutical companies world-wide and a growing proportion of the instruments employed are operated in GLP and GMP environments. Applications range from raw material acceptance, through to product release to market. A comprehensive application note, co-authored with Almac, describing such applications is available. Adherence to the principles data integrity (DI) and instrument qualification is mandatory for such instrumentation and, in response to multiple customer requests Bruker offers a "GxP readiness kit". This approach, which has been well received by our customers, includes an integrated suite of qualification protocols, together with associated documents that are available to support IQ/OQ and also Computer System Validation (CSV). Additionally, software to support PQ is also available.
Data Integrity
Regulatory agencies such as the FDA have a strong focus on the principles of data integrity and Bruker has incorporated multiple features into the latest versions of the software packages (TopSpin and iconNMR) that support compliant operations. Such features are continually being refined and extended. A white paper describing our approach is also available
The GxP assistance kit: User Benefits
The kit saves time, as the integrated package reduces effort and time required to achieve compliance, with on-site support being provided by a fully qualified service engineer Minimal disruption to the operation of existing systems (typically <2 days)
Qualification
Papers describing Bruker's general approach to instrument qualification is described in a white paper. A further white paper describes Performance Qualification (PQ) that suits the specific requirements of quantitative NMR
Compatibility
The kit is available for all Bruker high resolution systems (all existing magnets) running Topspin 3.5pl7 and above The readiness kit is applicable to new and existing systems (e.g. to support requests arising from change control) IQ and OQ protocols are also available for minispec systems (TD-NMR)
Learn More
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NMR under GxP in Drug Development and Manufacturing
(PDF, 2 MB)
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NMR in Pharma: Application of Data Integrity Principles
(PDF, 1 MB)
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NMR in Pharma: Instrument Qualification
(PDF, 848 KB)
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NMR in Pharma: The Principles of Change Control
(PDF, 1 MB)
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NMR in Pharma: Performance Qualification (qPQ)
(PDF, 2 MB)
Support
Service and Life Cycle Support
Bruker’s commitment to provide customers with unparalleled help throughout the buying cycle, from initial inquiry to evaluation, installation, and the lifetime of the instrument is now characterized by the LabScape service concept.
LabScape Maintenance Agreements, On-Site On-Demand and Enhance Your Lab are designed to offer a new approach to maintenance and service for the modern laboratory