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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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Compliance and Validation Research Study Complete!

We recently conducted compliance and validation research that focused on understanding pain points, trends and purchasing behaviours specific to the pharmaceutical industry in North America. The purpose of the research was to understand market opportunities related to the use of automated computer system validation software. To meet the objectives of the study, one-on-one interviews were conducted with executives within the industry. The interviewees comprised IT Directors, Quality Assurance & Compliance Directors and other executives knowledgeable about compliance and validation. The interviewees included executives from large pharmaceutical companies such as Merck, Novartis, Sanofi Pasteur and Bristol Myers-Squibb as well as mid and small-sized companies across the…


March 21, 2014 by
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Computer System Validation – How Much To Validate?

How much to validate is the biggest challenge facing validation professionals and their organizations.  Deciding how much to validate is a delicate balance between satisfying compliance requirements and the time it takes to implement critical technologies. Why is this a challenge for organizations?  When you consider compliance requirements you must first consider cost.  Validation is an overhead cost, not a profit driving business activity.   As a result the decision of how much to validate becomes an important question that impacts both time and money. The second point to consider is the company’s interpretation of FDA or other regulatory agency guidelines.   A lack of understanding of…


March 10, 2014 by
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