Laboratory Instrument Qualification is the foundation of analytical data integrity. Instrument and equipment qualification must be performed when a new instrument or item of laboratory equipment is brought into the laboratory. Equipment/Instrument qualification should also be performed when an instrument or item of equipment is moved to another bench, laboratory or site.
Qualification may be performed by the instrument manufacturer or a contract service provider. Generally, laboratories choose to perform the qualification using internal resources. Whoever performs the qualification, it is the responsibility of the laboratory and quality unit to assure that it is performed consistent with the regulations and current industry expectations and practice. The practice is outlined in USP Analytical Instrument Qualification. This process is also impacted by more contemporary guidance such as ICH Q10, The Pharmaceutical Quality System the 2011 FDA Process Validation Guidance, the EU GMP Annex 15; Qualification and Validation and a recent USP Stimulus article, Lifecycle Management of Analytical Procedures: Method Development, Procedure Performance Qualification, and Procedure Performance Verification.
This 90-minute audio session with expert speaker Dr. Jerry Lanese Ph.D will focus on the science, responsibilities of the laboratory and quality and current practices while discussing the instrument and equipment process in the qualification of laboratory instruments and equipment.
This training session will help personnel in the Test Method Development Laboratory, Quality Control Laboratory and Quality Assurance understand the laboratory instrument and equipment qualification process and their respective roles and responsibilities in a compliant completion of the instrument or equipment qualification project. The discussion will also include the impact of contemporary guidance on the implementation of USP.
The practice of qualification of analytical equipment and instruments has had mixed interest in the pharmaceutical industry. In the 1980s and 90s firms did nothing to qualify equipment. In the late 1990s, firms were doing much than required for the qualification of simple equipment such as ovens and mixers. Finally a group of laboratory personnel got together and worked with the USP to develop USP and provide a logical, scientifically sound approach to laboratory equipment and instrument qualification. This guidance provides valuable information on instrument qualification and the process implemented taking into consideration more recent guidance.
Who should attend
- Dr. David Lim
Dr. John G. (Jerry) Lanese is an independent consultant with a focus on Quality Systems and the components of an effective Quality System. He received a BA and MS from Middlebury College and a Ph.D. in Analytical Chemistry from the University of Michigan and began his career teaching Analytical Chemistry in a small liberal arts college. Dr. Lanese moved from the academic environment to the pharmaceutical industry where...
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