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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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How-to Apply Quality by Design (QbD) Principles to Process Validation

What does QbD mean for pharmaceutical companies? Quality by Design (QbD) refers to a set of risk-based principles, applied to manufacturing practices in order to ensure that the development and processes yield a quality product based on solid scientific and engineering principles. For pharmaceutical companies specifically QbD principles are based on regulations that have been around for several years (since 2006), such as ICH Q8 Pharmaceutical Development and ICH Q9 for Quality Risk Management and Q10 for Quality Systems. Thus, a majority of the QbD components for process validation are not unfamiliar. When helping to incorporate the QbD principles into our clients’ process validation practices,…


April 17, 2014 by
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The 3 Stages of Process Validation

What is process validation? Process validation refers to the documented evidence that processes are operated within established parameters and that it can perform effectively to fulfill its intended purpose. With the FDA asking for more scientific arguments to support activities, the “life cycle” approach to process validation was born, as it provides opportunities for process validation across the entire product lifecycle. The lifecycle approach to process validation can be described in three stages: 1.    Process design and development The first step in the process requires four main activities be performed: Definition of Quality Target Product Profile or (QTPP), in other words, how you want your…


April 9, 2014 by
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