Paul Smith is EMEAI laboratory compliance productivity specialist at Agilent Technologies UK Ltd, 610 Wharefedale Road, IQ Winnersh, Wokingham, Berkshire RG41 5TP, United Kingdom,
[email protected]
Spectroscopy - Dec 01, 2015
The United States Food and Drug Administration has issued a draft guidance on the development and submission of near infrared (NIR) analytical procedures. Here, we explain and critique key aspects of the document.
LCGC Europe - Feb 01, 2015
This instalment of “Questions of Quality” looks at problems with an operational liquid chromatograph to see if they can be picked up in the performance qualification (PQ) or prevented in the operational qualification (OQ).
Pharmaceutical Technology - May 02, 2014
Data integrity in the analytical laboratory is an area of increasing focus for regulators such as FDA.
Pharmaceutical Technology Europe - Sep 01, 2011
By providing an information "fingerprint", infrared red spectroscopy is a useful tool for identifying counterfeit pharmaceuticals. The authors identify best practices for ensuring compliance.
Pharmaceutical Technology Europe - Sep 01, 2010
Utilizing integrated active radio frequency identification (RFID) and real-time asset management systems can yield commercial and compliance benefits.