Talk:Clinical quality management system

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Citations cleanup 2016-12-16

I just made an effort to clean up citations. Even so, there is room for (significant) further improvement. rs2 (talk) 19:41, 16 December 2016 (UTC)[reply]

The citation that isn't (today) - MasterControl

During my review today of the article, the MasterControl 'citation' does not appear to be a citation and instead appears to just be an external link. For that reason, in my original update I moved it to 'External Links', but then I deleted the section based on External_links#Important_points_to_remember, which states "This specifically includes e-commerce and other commercial-sales links, which are prohibited in External links but allowed in footnoted citations."

Note: for this item, I did not attempt to search through the history, since it is a commercial link. Others should feel free to do so if they believe that the link provides reference value beyond its commercial connections (which it very well could).

Uncertain reference to Nasr FDA statement

Instead of the Nasr reference, this related FDA reference might be better: "Implementation of ICH Q10 throughout the product lifecycle should facilitate innovation and continual improvement..." from the FDA's "Guidance for Industry - Q10 Pharmaceutical Quality System" available at http://www.fda.gov/downloads/.../ucm073517.pdf (that link actually seems to have an ellipsis in it!)

The closest thing I could find to original material for the Nasr quote was this from p25 of Nasr's http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AdvisoryCommitteeforPharmaceuticalScienceandClinicalPharmacology/UCM272110.pdf

11 The third key guideline is ICH Q10
12 for pharmaceutical quality system. It
13 describes system that facilitates
14 establishment and maintenance of a state of
15 control for process performance, facilitates
16 continual involvement and applies to drug
17 substance, drug product, throughout product
18 life cycle and supply chain.