Continuous Manufacturing: Future is Here

June 6, 2016 by

For Improved Quality in Pharmaceutical Manufacturing, a cleaner, flexible, and more efficient manufacturing practice is here and it is called continuous manufacturing.   Traditional manufacturing practice in Pharmaceutical is known as “batch” manufacturing, a process that manufacturing experts from the 1950s would easily recognize.   The unique benefits of continuous manufacturing is integrated processing with fewer steps, smaller equipment and facilities, and real-time continuous product quality monitoring.  Contributing to reduce costs, improved product supply reliability, and a smaller ecological foot print. Continuous Manufacturing is also consistent with FDA Guidelines on Process Validation using Quality by Design principals.  (see our blog on FDA Guidelines on Process Validation: Then and Now) Regulators have been encouraging continuous manufacturing technology due to the imminent advantages to product and patients.  US FDA approval of Janssen Pharmaceutical Inc. continuous manufacturing production line in April 2016 is a milestone for Pharmaceutical industry. (See FDA Blog post on this milestone).  It is the first significant approval of a change of production method from batch based unit operation to a continuous manufacturing process. The Guidance for Industry on Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base, issued by US FDA in December 2015 provides recommendations to pharmaceutical companies interested in participating in a program involving the submission of chemistry, manufacturing, and controls (CMC) information containing emerging manufacturing technologies…

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Software Vendor Assessment Series

When looking into vendor or supplier assessments, Ray Carter’s list of 10 C’s (Competency, Capacity, Commitment, Control, Cash, Cost, Consistency, Culture, Clean, and Communication) comes to mind.  While this list contains a tried and true methodology, when it comes to picking vendors for software that will operate in a regulated environment, there are new variables introduced, and some elements become more critical than others, so we need to get more specific. We’ve designed this new blog series to walk you through the best practices for conducting complete vendor assessments when it comes to buying or developing software for your regulated business processes. Check out the…

January 10, 2014 by
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Electronic vs. Digital Signatures: The Compliance Factor

The pharmaceutical industry is evolving in regards to documentation, quality, efficiency and security. Automation is critical, therefore companies are rapidly moving to platforms that leverage paperless working environments in order to enhance quality, reduce costs and gain efficiency. A large component of automation is the ability to workflow documents electronically. This has sparked confusion and debate in regards to signatures, specifically electronic signatures versus digital signatures. These terms are widely misinterpreted and there isn’t clarity around how they impact compliance and regulations, such as 21 CFR Part 11. Compliance for any signature whether digital or electronic will always revolve around the key elements of information…

November 12, 2013 by
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