Posts Tagged ‘pharmaceutical manufacturing’

Data Integrity for Pharmaceutical and Biotech Manufacturers

Posted in Life Sciences, Regulatory Compliance on Tuesday, March 13th, 2018. No comments yet
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Update: This post has been updated with a link to the most recent Medicines & Healthcare products Regulatory Agency (MHRA) ‘GXP’ Data Integrity Guidance and Definitions – March 2018 document. For pharmaceutical, biotech and other manufacturers in highly-regulated industries, the production data is as important as the product itself for release to sale. Data integrity […]

Increasing Autoclave Reliability via Machine Learning Technology

Posted in Life Sciences on Tuesday, February 13th, 2018. No comments yet
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ARC Advisory Group’s Paula Hollywood moderated a session, IT/OT/ET Convergence at the 2018 ARC Industry Forum. Here’s the description from this session: The convergence of IT (Information Technology at the enterprise level) and OT (Operations Technology, the information and automation technologies employed in the plant), is not new, but the relationship is intensifying. What is […]

Managing the Chain of Identity in Cell Therapeutics Manufacturing

Posted in Life Sciences, Operations Management on Thursday, January 4th, 2018. No comments yet
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Medicines produced by pharmaceutical and biotech manufacturers are manufactured in many ways. One particular type of treatment, cell therapy, is defined as: …the transplantation of human or animal cells to replace or repair damaged tissue. From a manufacturing perspective, each therapeutic batch must be perfect the first time — because each batch is produced for […]

Successfully Implementing Process Analytical Technology

Posted in Life Sciences on Tuesday, October 31st, 2017. No comments yet
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It’s been well more than a decade since the U.S. Food & Drug Administration (FDA) announced a Process Analytical Technology (PAT) approach for pharmaceutical manufacturers in their Guidance for Industry PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance. While conceptually understandable, it has taken time for PAT to be put into […]

Pharmaceutical Wireless Instrumentation Retrofits

Posted in Life Sciences, Wireless on Wednesday, August 23rd, 2017. No comments yet
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Many industries have benefitted from the use of wireless instrumentation, but how about the pharmaceutical and biotech manufacturing industries? Are there applications which might improve the performance of their operations? In a Pharmaceutical Manufacturing article, Retrofitting Pharmaceutical Processes with WirelessHART Instrumentation, Emerson’s Michalle Adkins and Dan Carlson describe ways that these additional measurements and final […]