 | March 1, 2010
By:Ruud J.P. Goedknegt
There is more to using and interpreting certificates for chromatography standards than meets the eye
 |
 | December 1, 2009
By:R.D. McDowall
There is a new FDA Commissioner who wants a "strong FDA". Chromatographers must be prepared to be compliant and remain compliant — or else!
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June 1, 2009
By:R.D. McDowall
United States Pharmacopeia (USP) general chapter 1058 on analytical instrument qualification (AIQ) has finally become official and was released in August 2008 in the first supplement to the USP XXXI.1 This column reviews AIQ and discusses the impact it will have in the regulated chromatography laboratory.
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April 1, 2009
By:R.D. McDowall
This column discusses the similarities and differences between the validation approaches for analytical methods for QC product analysis and bioanalysis.
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October 1, 2008
By:R.D. McDowall
The regulatory world and associated guidance documents within the pharmaceutical industry is changing rapidly. This column gives an overview of what's happened since the start of the year.
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June 1, 2008
By:R.D. McDowall
You may work in a chromatography laboratory to quality standards but do you work to Good Laboratory Practice? Probably not...
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March 1, 2008
By:R.D. McDowall
The four eyes approach is a cornerstone of any quality system (GMP, GLP or ISO 17025): a first person performs a task and a second person checks it.
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November 1, 2007
By:R.D McDowall
Information from guidance documents used in clinical investigations can be very useful to help meet FDA regulations regarding computer security in analytical laboratories.
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March 1, 2007
By:R.D. McDowall
Users need to understand not only the operation of the computer system as required by their access privileges, but also the ethics and integrity required operating under any of the GMP or GLP quality systems.
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