Quality Matters Columns
Chris Burgess and John Hammond are back with an “Update on the modernisation of the spectroscopic General Chapters in the United States Pharmacopeia (USP)”. They review progress over the last three years and particularly on the changes intended in the USP Review Cycle 2015 to 2020.
John Hammond updates us on recent developments with the ISO 17xxx series of standards. John continues with news of standards particularly relevant to readers.
Peter Jenks and Alan Nichols embark on “ISO/IEC 17025: a never-ending journey”. They describe what is behind this recent standard and give valuable advice as to what to expect from an audit. Newcomers may find the requirements daunting, but Peter and Alan’s guidance will prove most helpful.
Chris Burgess and John Hammond look back 40 years to the start of GLP regulations and consider how closely qualification processes are aligned to quality by design principles.
Peter Jenks and Alan Nichols plot a path through the accreditation jungle and decide that “Confidence: the key to quality”. With increasing numbers of readers’ labs requiring auditing, ensuring that the reference materials and standards you are using meet the requirements of the auditors is essential.
Next year, a new version of ISO/IEC 17025 will be published, which is going to mean changes for all those involved in quality systems. Peter Jenks investigates.
“Is your spectrometer in calibration?” ask Chris Burgess and John Hammond. The answer may not be as straightforward as you might think. However, Chris and John explain all.
Peter Jenks looks back to the BERM 14 conference on biological and environmental reference materials in the Quality Matters Column. The next conference in the series returns to Europe: Berlin in June 2018.
In the Quality Matters Column, Peter Jenks, Paul Boother and Annette Marshall are concerned about “The proper use of certified reference materials for analytical instrumentation qualification”. There are many aspects to consider in ensuring the validity of an analytical system, from before any instrumentation is installed, before it is used and during its use. Readers interested in the chemicals and reference material field may be interested in the news that, as this issue was being prepared, Merck completed its $17-billion acquisition of Sigma-Aldrich.
In the “The analysis of poly aromatic compounds: a never-ending story?”, Peter Jenks reports from the 25th International Symposium on Poly Aromatic Compounds. He was disappointed to find the near total absence of mention of the use of CRMs in method development or as a calibration material. He concludes that “data from the academic and research community often acts as a stimulus for government concern and the data may ultimately may result in legislation. It concerns me that legislation may be driven by bad data”.
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