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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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Software Vendor Assessments Part 2: Show Me The Money!

During a vendor assessment you will be asking them to produce a lot of documentation to prove that they have quality processes in place.  However, it is important to understand that simply reading their documentation that describes a process is  not enough.  That is only one part of the audit. The second part that always goes hand in hand with the documentation is proof that they are following those procedures.   If a process says that they collect metrics for training via surveys to improve performance based on feedback, then ask to see if they have those forms.  If there is a support and help desk…


January 20, 2014 by
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Software Vendor Assessments Part 1: Why Do We Audit Software Vendors?

Out of all potential vendors, the audit for software vendors has the most value, for one  clear-cut reason – to determine the level of quality they will produce. When it comes to raw materials, packaging materials, tools, equipment, etc., there is a level of measurable quality because you can physically interact with those products, and sensibly evaluate them. With software that is not the case. What is being provided to us is really an interface, with a large body of coding behind it, making the real work intangible.   After we get the software from the vendor, there is no other option but to use it,…


January 10, 2014 by
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