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- The OECD Principles of GLP
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2. Scope and application
- Mr. David Long
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3. Performing test systems and test items
- Prof. Sergio Caroli
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4. Why OECD GLP and not ISO / IEC 17025?
- Dr. Helen Liddy
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5. Principles of GLP
- Mr. David Long
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6. Performing: standard operating procedures
- Mrs. Katariina Rautalahti
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7. GLP: planning, recording, and archiving
- Mr. Phil Withers
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8. Reporting of study results
- Mr. Hedwig Beernaert
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9. Quality assurance
- Mr. David Long
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10. Facilities: buildings and equipment
- Mr. Hedwig Beernaert
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11. Multi-site studies and field studies
- Dr. Geetha Rajashekhar
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12. In vitro studies and short term studies
- Prof. Sergio Caroli
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13. Computers in a GLP environment
- Mr. John McNamee
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14. The application of the GLP principles in analytical chemistry
- Prof. Sergio Caroli
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15. Good laboratory practice: roles and responsibilities
- Mr. David Long
- Monitoring GLP Compliance
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16. Monitoring GLP compliance: history and OECD framework
- Mr. Richard Sigman
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18. Inspection procedures
- Mr. Theo Helder
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20. GLP in the European Union
- Mr. Maik Schmahl
- International Data Acceptance Through OECD
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22. International data acceptance through OECD: history and OECD context
- Mr. Richard Sigman
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24. Participation of non-OECD economies in the MAD system
- Ms. Christinah Leballo
Printable Handouts
Navigable Slide Index
- Introduction
- Introductory comments
- Standard operating procedures
- Maintenance
- Equipment failure
- Only a small number of instruments are critical
- Reliability-centred maintenance
- GLP inspector should check all SOPs available
- Stick to the GLP principles!
- Major types of technical equipment
- General-purpose devices
- Physical-chemical apparatuses
- Analytical instrumentation
- Examples of analytical techniques
- Scheme of an LC-ICP-MS system, example 1
- Scheme of an LC-ICP-MS system, example 2
- Scheme of an LC-ICP-MS system, example 3
- Inspector need to assess use & maintenance
- Scope of method validation
- Validation refers to analytical systems
- Each system has a specific field of application
- Validation procedures
- Method performance characteristics
- System validation and GLP inspections
- Check-list of validation items
- Inspector should ask for documented evidence
- The ultimate goal of validation
- Suitability of equipment
- Concentrate on aspects where errors are greatest
- Method development, optimization, validation
- Inspector must check validated methods in place
- GLP validation is more expensive
- Validity depends on reliability of information
- Technical personnel
- The TFM
- The policy of the TFM
Topics Covered
- Analytical chemistry
- Calibration of analytical equipment
- Failure of equipment
- Hyphenated analytical techniques
- Inspections of Good Laboratory Practice-compliant test facilities
- Integrity of studies
- Maintenance of analytical equipment
- Physical-chemical apparatuses
- Principles of Good Laboratory Practice
- Standard Operating Procedures
- Validation of analytical systems
Talk Citation
Caroli, S. (2013, July 18). The application of the GLP principles in analytical chemistry [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved May 14, 2024, from https://hstalks.com/bs/2593/.Export Citation (RIS)
Publication History
Financial Disclosures
- Prof. Sergio Caroli has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.