Column: Focus on Quality

Sep 01, 2013
Spectroscopy
By Spectroscopy Editors
In pharmaceutical contract manufacturing, the work of analytical scientists is covered by a quality agreement, which is prepared by personnel in the quality control or quality assurance department and focuses on the laboratory analyses provided. But what exactly are quality agreements, why do we need them, who should be involved in writing them, and what should they contain? Here, we answer those questions.
Apr 01, 2013
Spectroscopy
By Spectroscopy Editors
A look at what the requirements are for "complete data" for laboratories working under the FDA GMP regulations. We also review the observations listed by inspectors on 483 forms from 2006 to 2012, to assess the common mistakes companies make.
Dec 01, 2012
Spectroscopy
By Spectroscopy Editors
Answers to common questions about operational qualification (OQ) software
Nov 01, 2012
Spectroscopy
By Spectroscopy Editors
A look at how the term commercial off-the-shelf can be abused in marketing literature.
Sep 01, 2012
Spectroscopy
By Spectroscopy Editors
Guidelines for writing standard operating procedures in a laboratory and best practices for their use.
Apr 01, 2012
Spectroscopy
By Spectroscopy Editors
A discussion of the various options for cloud computing, avoiding the marketing hype and focusing on the potential advantages and disadvantages for your laboratory
Dec 01, 2011
Spectroscopy
By Spectroscopy Editors
Here's what needs to be done to harmonize these two documents.
Nov 01, 2011
Spectroscopy
By Spectroscopy Editors
Continued discussion of the periodic review process, including how to conduct a review, the use of checklists, and reporting the outcome
Sep 01, 2011
Spectroscopy
By Spectroscopy Editors
Annex 11 to the EU's updated GMP regulations calls for periodic re-evaluation of computerized systems. This is what you need to know about the new rules.
Apr 01, 2011
Spectroscopy
By Spectroscopy Editors
The revisions to GMP Annex 11 are examined in terms of the impact on computerized spectrometry systems operating in regulated GMP laboratories.
native1_300x100
lorem ipsum