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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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FDA Guidelines for Process Validation: Then and Now

Difference between the 1987 and 2011 FDA Guidelines for Process Validation – an overview It’s been over 20 years since the guidelines for process validation were updated. The FDA’s 1987 guidance document, Guideline on General Principles of Process Validation was replaced January of 2011 when the FDA published the updated  Guidance for Industry-Process Validation: General Principles and Practices. The new guidelines introduces new concepts and principles and denotes the evolution in process validation requirements. Like other guidelines, they are not law, but adherence to them provides a good framework for building a compliance program. What Changed? The 1987 definition of process validation defined process validation…


September 17, 2015 by
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