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Continuous Manufacturing: Future is Here

June 6, 2016 by
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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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Quality By Design and Process Validation

The FDA has made significant progress in implementing the concepts of “Quality by Design” (QbD) into pre-market processes. The QbD concept is that quality should be built into a product through a deep understanding of the product, both how it’s developed and how it’s manufactured. A comprehensive understanding of the risks involved in manufacturing a product and how best to mitigate those risks is also required.The QbD initiative attempts to provide guidance on pharmaceutical development to facilitate design of products and processes with  maximum  efficacy, safety profile and product manufacturability.  QbD  forms the basis of process validation activities conducted by pharmaceutical manufacturers in validating their…


February 12, 2014 by
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Software Vendor Assessments Part 3: Conducting the Assessment

What to Assess? This breakdown targets the essential factors that require attention when conducting vendor assessments for software vendors producing systems designed to work within a regulated environment. The Facility Tour Whether the vendor occupies an entire building or one floor in an office building, getting a quick tour of the premises tells you a lot about how the vendor operates.  Always make the data centre a part of your tour to see how data and documentation are being secured and stored.  Be sure to observe cleanliness and habitation practices as well, as the overall look, feel, and organizational culture will be reflective of how…


January 28, 2014 by
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