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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 Associates Announces Release of Validation Automation Tool for Process Validation, PV VALIDATOR

July 24, 2015 by
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Company Has Product Offerings for Both Computer System Validation and Process Validation Toronto, ON –  Understanding and keeping pace with the world of regulatory compliance can be time consuming. Companies need to be able to quickly respond to changes, but this can be hard with the current state of Process Validation. Compliance Associates releases a new product offering that promises to streamline the process – PV Validator for Process Validation Lifecycle Management. PV Validator is a web-based application that uses principles of Process Validation to establish scientific evidence for consistently manufacturing quality products. The system incorporates instrumental Risk Assessment and Statistical Evaluation tools. Organizations wanting to achieve excellence require a system that will facilitate the creation and management of all inputs and outputs of their processes, a system that will interface with all enterprise systems contributing to said process. Key Benefits PV Validator is a step toward improved product development, quality and process management. Companies will be able to respond to rapid changes, shorten time to revenue, and reduce process risks. The system allows for collection and evaluation of data through all stages of Process Validation, thus helping in establishing scientific evidence for consistently manufacturing quality products. PV Validator facilitates application of Process Validation Guidelines (Ex. FDA, EMA, WHO) and the Quality By Design (QbD) approach. An automated system can greatly streamline the…


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