Mass
Spectrometry SOP's
and other cGMP related stuff
Articles:
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Auditing and the Analytical Laboratory : "The key to a good audit is to have a sound laboratory cGMP program in place and to follow it judiciously to ensure regular and ongoing compliance." Author: Clifford L. Nilsen, Link to Article at Phamaceutical Formulation and Quality
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Pharma IT: After GMP and GLP, it's time for Good Clinical Practices: "Increased clinical research data complexity and volume have resulted in greater need for electronic records management." Author: Mark S. Ferrero, Link to Article at Phamaceutical Formulation and Quality
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Training: Making the Compliance and Procedural Training Touchdown: Companies have to be good at blocking and tackling to achieve winning compliance. Author: Mike Starke, Link to Article at Phamaceutical Formulation and Quality
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Surviving an FDA Inspection of Your Clinical Site Author: Steve Mayo, Link to Article at Emissary Inc.
Links to the FDA
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Guidance for Industry COMPUTERIZED SYSTEMS USED IN CLINICAL TRIAL
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A good site for cGMP is www.labcompliance.com
- "An Introduction to Mass
Spectrometer Standard Operating Procedures"
- - "Instrument Type Format,
Title: Maintenance and Calibration of a Mass Spectrometer"
- - "Instrument Type Format,
Title: Use and Maintenance of a Tandem Triple Quadrupole Mass Spectrometer"
- - "Specific Instrument
Format, Title: TSQ 700, USE AND MAINTENANCE"
- - "Instrument type format with separate method specific instrument operation procedures, Title: Tuning and Calibration of Quadrupole Mass Spectrometers"
Has the FDA Inspected Your Mass Spectrometry Laboratory?
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Last updated: Friday, January 19, 2007 12:51:05 AM