FDA audit war rooms are now antiquated and old-school for companies with modern quality systems. Do not discount the credibility that openness and transparency brings to an audit. Many think the war room during an FDA audit is standard practice; the war room is for “organizing quality documents and staging employees for meeting with [...]
Learning from Traceability Improvement – The Eggo Recalls of 2009 and 2016 2009 - The Year Kellogg Leggo of the Eggo On August 31st 2009, a laboratory test by the Georgia Department of Agriculture (GDA), found Listeria monocytogenes in a sample of Eggo waffles. Kellogg Co. recalled 4 production runs totaling nearly 4,500 cases of Eggo products [...]
7 Tips for User-Friendly Warehouse Barcoding. You want the advantages of a barcoded warehouse if you manufacture or package FDA regulated products. Especially if you have already suffered through the inventory spreadsheets, clipboards and cycle counts, or even the awkward interfaces of a current inventory “tracking” system– printing out [...]
Smart companies use public information for strategic advantage. This article explains how new cGMP regulations are issued for pharmaceutical, medical device, e-liquid, and dietary supplement manufacturing industries. Since the most recent push for new regulation has been in the vaping and e-liquid space, we will use that industry as the primary example. On May 5, [...]
Using paper for your batch records has advantages. Paper acts as a bookmark for a process or a physical baton of responsibility. Paper is easy, it’s well accepted, and by sticking with paper batch records you won’t have to deal with any CFR 21 Part 11 electronic signature nuances. Plus, paper is “cheap,” right? Some [...]
