Peter Jenks argues that the two quality approaches, ISO 17025 and cGMP, are both lacking, but both could be made much better and virtually identical with single but different improvements!
Quality Matters Column
Quality Matters addresses the ever-increasing importance, and complexity, of ensuring that our analyses are correct. Chris Burgess, John Hammond and Peter Jenks guide readers through the minefield of ISO standards and how they affect the spectroscopic community.
Chris Burgess is an internationally recognised expert in the qualification and validation of instrumentation and systems, analytical method development & validation and the statistical interpretation of data. In addition he has extensive experience in quality systems design and development for the whole supply chain and has acted as a Qualified Person within the EU for more than 25 years.
John Hammond is an experienced analytical scientist, spectroscopist and technical marketing professional. John is internationally recognised in the field of Reference Material production and certification for use in the field of UV-Visible-NIR spectroscopy, currently Chair of ASTM International committee E13 on Molecular Spectroscopy and Separation Science, Convenor of Working Group 6—Information Services for ISO/REMCO, and a member of the USP General Chapters—Chemical Analysis Expert Committee.
Peter Jenks has over 30 years experience in analytical, environmental and pharmaceutical businesses. During this time he has promoted the use of Certified Reference Materials (CRMs) in support in of ISO 17025 Accredited Laboratories and worked with suppliers to improve both availability of CRMs and their proper use. He has set up new businesses to produce and distribute CRMs and consulted for key industry stakeholders.
Peter Jenks and John Hammond describe how the important ISO 17025 standard has developed, and point out that a review for the third edition of the standard will start soon. All those with an interest in quality standads—an increasing number of us—should make sure their voice is heard at their local standards body.
Peter Jenks has discovered quantitative NMR. in his article titled “NMR: is it the future for the analysis of organic molecules?”. If only it wasn’t so expensive, it might be the perfect method to certify pure organic compounds.
Peter Jenks and John Hammond continue their series on “CRMs and PT in an ISO 17025 accredited laboratory” with instructions on how you can prepare your own in-house certified reference materials.
Peter Jenks looks at some current trends in the supply of CRMs and proficiency testing and highlights difficulties labs may have been when no commercial CRM is available. This will be followed with a second part looking at the production of in-house reference materials.
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- Atomic absorption
- Atomic emission
- Ion mobility
- Laser spectroscopy
- Mass spectrometry
- Near infrared
- NMR ESR EPR
- North America
- Related equipment
- RMs and standards
- Separation science
- South America
- Surface analysis
- X-ray spectrometry