SharePoint is an off-the-shelf configurable software solution that has been offered by Microsoft since 2001. It is popular in many industries (including Biotech, Pharmaceutical, and Medical Device) for document management, local Intranet, and many other applications. However, if SharePoint is being used for any GxP purpose, you better believe it is subject to 21CFR11 and/or Annex 11. Continue reading Can SharePoint Online be Compliant?
Hello good people of the world! Today’s post is on the commissioning and qualification of instruments used in process measurement and control. Instruments may be used to measure such things as flow, temperature, pressure, level, weight, conductivity, etc. In use, many of these parameters may be quality critical, so proper commissioning and qualification is key! Continue reading Commissioning and Qualification of Process Instrumentation
Hello good people of the world! Today’s post covers some of the “golden rules” on aseptic biopharmaceutical manufacturing facility design. Please add yours in the comments below! Continue reading Golden Rules for Aseptic BioPharmaceutical Manufacturing Facility Design
Hello good people of the world! If you work with a mix of process equipment and supervisory control or monitoring systems, you know the importance of alerts and alarms, but most companies do not take the necessary steps to ensure their alerts and alarms are well configured and meaningful. One of the enemies is so-called “nuisance-alarms,” but just as important is knowing that you have enough alerting/alarming so that critical events are not missed and appropriate actions are taken before harm is done.
And by the way, alerts and alarms are something the FDA has historically shown to care about (e.g. FDA had observation at Teva Irvine for lack of validation on alerts and alarms). So what considerations are at play?
What should alert/alarm? If you’ve clearly defined your Critical Process Parameters (CPPs) and know what your Critical Quality Attributes (CQAs) are, you know already what needs alerts/alarms: all CPPs.
What should the alert/alarm limits be? This part is tricky: you need limits that provide operators with sufficient information without becoming a nuisance. All too often I see the situation where alarm banners are flashing but no one is paying attention because “there’s always alarms” or whatever.
What action should occur based on alert/alarm conditions? This is another place I often see improvements needed: every alert and alarm should have a documented action associated with it, typically in the SOP, that operators are trained on. If there is no documented action required for an alert/alarm, why do you have it?
What do you find critical in configuring alerts/alarms and introducing them into a manufacturing process?
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