Jennifer A. Maguire @quality_sleuth
Deputy Director, Office of Quality Surveillance, OPQ/CDER/FDA The views and information presented here are mine. Maryland, USA Joined May 2020-
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Time is running out to participate in this #FDA #OPQ global quality benchmarking study. To clarify, quality metrics are just ONE part of quality management maturity which also includes quality culture, supply chain mgmt, risk mgmt, QMS, etc...
“We are committed to making decisions guided by the best evidence. Our approach has been and must remain the gold standard that all can rely upon.” #FDA #OPQ usatoday.com/story/opinion/…
Hear me on the new @DunBradstreet “Power of Data” podcast talking about the global quality benchmarking study of pharmaceutical manufacturers funded by #FDA #OPQ. Listen on streaming platforms including Apple Podcasts, Google Podcasts, Spotify. dnb.com/perspectives/p…
And if we only knew more about the overall state of manufacturing quality management practices in the drug industry. Hmmm… if only there was some way… dnb.com/marketing/phar…
And if we only knew more about the overall state of manufacturing quality management practices in the drug industry. Hmmm… if only there was some way… dnb.com/marketing/phar…
CDER’s Valerie Jensen on #COVID19 & drug shortages: “We've been in contact with over 180 drug manufacturers making sure they notify of us of any time there's going to be any potential supply disruption so we can work with them.” #FDA #OPQ
The latest update on hand sanitizers you should NOT use. #FDA #OPQ discovered serious safety concerns with some hand sanitizers during recent testing.
Jennifer A. Maguire retweeted
Time is running out to be on the right side of history in pharma! Please help DunBradstreet & @HSGStGallen establish the 1st global baseline of manufacturing quality management practices. Learn how YOU compare to the global baseline. #FDA #OPQ lnkd.in/ekxyUSr
Some hand sanitizer products have tested positive for 1-propanol contamination, which can be toxic and life-threatening if ingested. Yesterday #FDA #OPQ expanded the “do-not-use” list of hand sanitizers to include these products. fda.gov/drugs/drug-saf…
Jennifer A. Maguire retweeted
To ensure harmful levels of methanol are not present, #FDA #OPQ updated guidances to provide clarification on testing alcohol for hand sanitizers. Also, @USPharmacopeia intends to revise alcohol monographs to include a ‘Limit of Methanol’ test. lnkd.in/dxv95JP
.@PDAonline covers Global Quality Benchmarking Study by @DunBradstreet & @HSGStGallen funded by #FDA #OPQ. All pharma companies are invited to this free assessment, each establishment receives a custom benchmarking report. All data confidential. pda.org/pda-letter-por…
It's live! fda.gov/media/138711/d…
Hand sanitizer: “Based on careful consideration of available data, we are specifying interim levels of certain impurities that can be tolerated for a relatively short period of time, given the emphasis on hand hygiene” #FDA #OPQ #COVID19 fda.gov/news-events/pr…
“Mgmt should create a quality culture that is transparent & open, in which personnel are encouraged to freely communicate failures & mistakes, incl potential data reliability issues, so that corrective & preventive actions can be taken.” #FDA #OPQ pink.pharmaintelligence.informa.com/PS142265/Data-…
#FDA #OPQ is using all quality surveillance tools available while inspections are postponed due to #COVID19. This contributes to generics approvals. Still, if an inspection is necessary, an application may not be approved.
My #FDA #OPQ Office of Quality Surveillance is funding a study by Dun & Bradstreet and the University of St.Gallen to benchmark pharmaceutical quality management practices. Study will produce a global baseline among drug manufacturers. Interested? lnkd.in/eb8A6Vg
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